Device recall: enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual…
Class II FDA enforcement event 81600. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Cosmetic imperfections on the surface of some lenses.
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
Bausch & Lomb Surgical, Inc. started this device recall on 5 Nov 2018. The firm address in the FDA record is in Clearwater, FL. FDA put the recall in Class II. FDA event 81600 has 1 product record. The first FDA enforcement report date is 26 Dec 2018. The record gives the status Terminated, with the termination date 4 Nov 2019.
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: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL IN, KS, KY, la, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI,…
Recalling firm
Bausch & Lomb Surgical, Inc., Clearwater, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0628-2019 | enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. The lens is intended for placement in the capsular bag. | 70,440 units | Class II | Terminated | 26 Dec 2018 |
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 2018
- 1,074
- Share of these events in Class II
- 92%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 8
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 6 Jun 2025 | Akreos, SKU: AO60P0300. Akreos intraocular lenses | Device | Class III | 1 |
| 27 Mar 2025 | Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; e | Device | Class I | 2 |
| 7 Nov 2020 | MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is in | Device | Class II | 1 |
| 9 Jun 2020 | enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary | Device | Class II | 1 |
| 5 Apr 2017 | SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or | Device | Class II | 1 |
| 26 May 2015 | Bausch & Lomb SofPort Advanced Optics Aspheric Lens | Device | Class II | 2 |
| 16 Oct 2013 | Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0628-2019The 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.
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Cite this page
Recall Register. FDA enforcement event 81600. https://recallregister.com/fda/ii/81600/. 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: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL IN, KS, KY, la, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI,…
- What quantity of product is in FDA event 81600?
- The FDA record gives this quantity:
70,440 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 92% of the 1,074 device events that started in 2018 are in Class II.