TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
- Recall Initiated
- April 6, 2022
- Recall Number
- Z-1033-2022
- Firm Location
- Santa Ana, CA
Reason for Recall
Potential breach in the sterility barrier for tray ring covers.
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.
Lot / Code Info
All Lots within Expiry: GTIN:05050474520707
Root Cause
Under Investigation by firm
Action Taken
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.