FDA Medical Device Recalls (openFDA)
Advanced Medical Optics, Inc.: AMO Healon D Ophthalmic Viscosurgical Device, Product Code: 10204011, Lot Number: UD30654, 30 mg/mL fill size
- Recall number
- Z-0343-2009
- Recalling firm
- Advanced Medical Optics, Inc.
- Product
- AMO Healon D Ophthalmic Viscosurgical Device, Product Code: 10204011, Lot Number: UD30654, 30 mg/mL fill size
- Status
- Terminated
- Initiated
- 2008-10-29
- Posted
- 2008-12-10
- Terminated
- 2012-02-21
- Reason
- Endotoxin levels above specifications have been noted in some syringes tested for lot number UD30654 of the AMO Healon D Ophthalmic Viscosurgical Device. Endotoxin levels above the maximum USP level may be potential causes of an inflammatory response and/or TASS in patients following surgery.
- Root cause
- Process design
- Action
- On Thursday, October 30, 2008, AMO began distribution of an Urgent Device Recall Notice via Federal Express overnight delivery to the twenty-six (26) AMO Healon D OVD, Lot UD30654, customer accounts in the United States. The Urgent Device Recall Notice include& a facsimile reply form. The Recall Notice informed the customers that AMO has received reports that some physicians using lot number UD30654 of the AMO Healon D OVD have observed an inflammatory reaction in their patients at the one-day post-operative visit. The customers were asked to undertake the following actions: (1) STOP using and remove from your inventory all units of AMO Healon D OVD, Lot UD30654. (2) Complete the included Facsimile Form making sure to note on the Facsimile Form the Quantities of AMO Healon D OVD present in your facility to be returned to AMO and fax to AMO Customer Service at 714-247-8722 within the next three (3) business days. The customers were also informed that an AMO Customer Service Representative will be contacting them to assist with the return of product affected by this action. If they have AMO Healon DC OVD units to be returned as part of this recall event and have not been contacted by an AMO Customer Service Representative, please call our toll free number at 1-877-AMO-4LIFE (1-877-266-4543) so that we can arrange the return of the product.
- Quantity
- 1450
- Distribution
- Nationwide to: MA, NJ, NY, WV, NC, SC, KY, OH, IN, MI, MN, OK, TX, WY OR, WA and Puerto Rico
- Lot, serial or model codes
- Lot Number: UD30654
- 510(k) numbers
- not on file
- PMA numbers
- ["P880031"]
- Product code
- LZP
- Firm FEI
- 3003843509
- Firm city
- Santa Ana
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28