Device recall: Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751…
Class II FDA enforcement event 77023. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
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
Abbott Medical Optics Inc. (AMO) started this device recall on 1 Apr 2017. The firm address in the FDA record is in Santa Ana, CA. FDA put the recall in Class II. FDA event 77023 has 6 product records. The first FDA enforcement report date is 17 May 2017. The record gives the status Terminated, with the termination date 27 Nov 2017.
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 and worldwide: Austria Belgium Croatia Czech Republic Denmark Finland France Germany Great Britain Iceland Ireland Israel Italy Latvia Lebanon Lithuania Netherlands Norway Portugal Spain Sweden…
Recalling firm
Abbott Medical Optics Inc. (AMO), Santa Ana, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
6 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2062-2017 | Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701 | 293,867 units total | Class II | Terminated | 17 May 2017 |
| Z-2063-2017 | Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014 | 293,867 units total | Class II | Terminated | 17 May 2017 |
| Z-2064-2017 | Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012 | 293,867 units total | Class II | Terminated | 17 May 2017 |
| Z-2065-2017 | Healon 5 Pro, Part No. 10270015 | 293,867 units total | Class II | Terminated | 17 May 2017 |
| Z-2066-2017 | Healon Pro, Part No. 10270012 | 293,867 units total | Class II | Terminated | 17 May 2017 |
| Z-2067-2017 | Healon V, Part No. 10290045 | 293,867 units total | Class II | Terminated | 17 May 2017 |
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 2017
- 1,091
- Share of these events in Class II
- 93%
- Product records in this event
- 6Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 30 Mar 2017 | AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP | Device | Class II | 1 |
| 26 Aug 2016 | SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual corre | Device | Class II | 10 |
| 6 Nov 2014 | Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile | Device | Class II | 1 |
| 20 Dec 2012 | AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviole | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2062-2017The 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 77023. https://recallregister.com/fda/ii/77023/. 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 and worldwide: Austria Belgium Croatia Czech Republic Denmark Finland France Germany Great Britain Iceland Ireland Israel Italy Latvia Lebanon Lithuania Netherlands Norway Portugal Spain Sweden…
- What quantity of product is in FDA event 77023?
- The event has 6 product records. The first record gives this quantity:
293,867 units total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2017 have the same class?
- 93% of the 1,091 device events that started in 2017 are in Class II.