Device recall: BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures.
Class II FDA enforcement event 90946. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
MEDLINE INDUSTRIES, LP - Northfield started this device recall on 30 Sep 2022. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class II. FDA event 90946 has 13 product records. The first FDA enforcement report date is 9 Nov 2022. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
13 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0155-2023 | BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures. | 95 kits | Class II | Ongoing | 9 Nov 2022 |
| Z-0156-2023 | BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures. | 160 kits | Class II | Ongoing | 9 Nov 2022 |
| Z-0157-2023 | BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures. | 800 kits | Class II | Ongoing | 9 Nov 2022 |
| Z-0158-2023 | BAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. Convenience kit used in surgical procedures. | 300 kits | Class II | Ongoing | 9 Nov 2022 |
| Z-0159-2023 | BAUSCH + LOMB EYE MUSCLE, REF VAL036EMESB. Convenience kit used in surgical procedures. | 16 kits | Class II | Ongoing | 9 Nov 2022 |
| Z-0160-2023 | BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures. | 28 kits | Class II | Ongoing | 9 Nov 2022 |
| Z-0161-2023 | BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures. | 708 kits | Class II | Ongoing | 9 Nov 2022 |
| Z-0162-2023 | MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures. | 96 kits | Class II | Ongoing | 9 Nov 2022 |
| Z-0163-2023 | MEDLINE LINQ TRAY, REF DYNJ65880A. Convenience kit used in medical/surgical procedures. | 40 kits | Class II | Ongoing | 9 Nov 2022 |
| Z-0164-2023 | MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures. | 60 units | Class II | Ongoing | 9 Nov 2022 |
| Z-0165-2023 | MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures. | 240 kits | Class II | Ongoing | 9 Nov 2022 |
| Z-0166-2023 | MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedures. | 50 kits | Class II | Ongoing | 9 Nov 2022 |
| Z-0167-2023 | CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit used in medical procedures. | 50 kits | Class II | Ongoing | 9 Nov 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 13Median of the firm: 2
- Events of the firm on the register
- 120
Other events of the firm
Official channels
- FDA enforcement report Z-0155-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 90946. https://recallregister.com/fda/ii/90946/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
- What quantity of product is in FDA event 90946?
- The event has 13 product records. The first record gives this quantity:
95 kits
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.