Recall Z-1033-2022 ยท HQC Unit, Phacofragmentation
Johnson & Johnson Surgical Vision Inc
TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
| Date | Apr 6, 2022 |
| Status | Open, Classified |
| Reason | Potential breach in the sterility barrier for tray ring covers. |
| Root cause | 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951462 | AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM Allergan Medical Optics, Jun 15, 1995 |