Z-1033-2022Class II

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

Name: Z-1033-2022 TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only
Creator: Johnson & Johnson Surgical Vision Inc
Published: 2022-04-06
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2022-04-06 / Open, Classified / root cause: packaging

FDA source

Johnson & Johnson Surgical Vision Inc began a recall of TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only on 2022-04-06. FDA classified it as Class II and gives the reason as "Potential breach in the sterility barrier for tray ring covers". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1033-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-06
Posted: 2022-05-04
Recalling firm: Advanced Medical Optics, Inc.
Product: TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Product code: HQC Unit, Phacofragmentation
Reason for recall: Potential breach in the sterility barrier for tray ring covers.
Root cause tag: packaging
FDA 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 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.
Product codes and lots: All Lots within Expiry: GTIN:05050474520707

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1033-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1033-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-11	2022-05-04

Product code HQC

K951462Class IIAmo Profinesse III Ultrasonic Handpiece SystemAllergan Medical Optics / cleared 1995-06-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)