Advanced Medical Optics, Inc. AMO Healon D Ophthalmic Viscosurgical Device, Product Code: 10204011, Lot Number: UD30654, 30 mg/mL fill size Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AMO Healon D Ophthalmic Viscosurgical Device, Product Code: 10204011, Lot Number: UD30654, 30 mg/mL fill size
Brand
Advanced Medical Optics, Inc.
Lot Codes / Batch Numbers
Lot Number: UD30654
Products Sold
Lot Number: UD30654
Advanced Medical Optics, Inc. is recalling AMO Healon D Ophthalmic Viscosurgical Device, Product Code: 10204011, Lot Number: UD30654, 30 mg/mL due to Endotoxin levels above specifications have been noted in some syringes tested for lot number UD30654 of the AMO Healon D Ophthalmic Viscosurgical Devi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026