TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING… recallZ-1033-2022 · Johnson & Johnson Surgical Vision Inc · initiated Apr 6, 2022

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Johnson & Johnson Surgical Vision Inc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential breach in the sterility barrier for tray ring covers.

FDA root cause category: Under Investigation by firm

What the company is doing

On April 11, 2022, Johnson & Johnson Surgical Vision, Inc. (JJSV) issued an "Urgent Medical Device Recall" Notification to all affected consignees via UPS. In addition to informing consignees about the recalled device, JJSV asked consignees to take the following actions: 1. Identify if any of your inventory contains Johnson & Johnson Surgical Vision Tray Ring Covers with Part Number OM271000. 2. Immediately discontinue using and remove from your inventory all affected Tray Ring Covers (P/N: OM271000). Note that no other JJSV Tray Ring Covers are affected by this recall. 3. EVEN IF YOU HAVE NO INVENTORY, please complete the attached Customer Reply Form (on page 4). JJSV requires this information for reconciliation purposes with regulatory agencies. 4. If you have inventory of the Tray Ring Cover with part number OM271000, please complete the Customer Reply Form, noting the Lot numbers of the Tray Ring Covers, and contact Customer Support at 1-877-266-4543 Option 2 to obtain a RGA number and arrange the product return.

Recall details

Recall number: Z-1033-2022
Status: Open, Classified
Initiated by the company: Apr 6, 2022
Recalling firm: Johnson & Johnson Surgical Vision Inc
Product code: HQC
FDA submissions: K951462
Distribution: Worlwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, MA, MD, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OR, PA, TN, TX, WA, WI and the countries of Chile, Indonesia, India, Japan, Malaysia, Philippines, Taiwan.

Product description

TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,

Code information (models, lots, serial numbers)

All Lots within Expiry: GTIN:05050474520707

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

NA OM271000
Johnson & Johnson Surgical Vision, Inc. · Unit, phacofragmentation
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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