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U.S. Department of Health and Human Services

Class 2 Device Recall Tray Ring Cover

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  Class 2 Device Recall Tray Ring Cover see related information
Date Initiated by Firm April 06, 2022
Create Date May 04, 2022
Recall Status1 Open3, Classified
Recall Number Z-1033-2022
Recall Event ID 89991
510(K)Number K951462  
Product Classification Unit, phacofragmentation - Product Code HQC
Product TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Code Information All Lots within Expiry: GTIN:05050474520707
Recalling Firm/
Manufacturer		 Johnson & Johnson Surgical Vision Inc
1700 E Saint Andrew Pl
Santa Ana CA 92705-4933
For Additional Information Contact JJSV Customer Service
877-266-4543 Ext. 2
Manufacturer Reason
for Recall		 Potential breach in the sterility barrier for tray ring covers.
FDA Determined
Cause 2		 Under Investigation by firm
Action 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.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HQC and Original Applicant = ALLERGAN MEDICAL OPTICS
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