Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens (IOL) is an acr
FDA device recall Z-2708-2016 · posted 2016-09-01 · Terminated
Recall details
- Recalling firm
- Alcon Research, Ltd.
- Reason for recall
- The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in the IOL becoming lodged in the Delivery System
- Action taken
- Alcon Research sent an Urgent Field Safety Notice letter dated July 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check their inventory and segregate any product being recalled. Customers were asked to complete and return the Field Safety Notice Response Form. For questions or concerns contact Alcon.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HQL
- Quantity affected
- 371 units
- Distribution
- Armenia, Belgium, Bulgaria, Croatia, Finland, France, Germany, Hungary, Italy, Lithuania, Malaysia, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Slovenia, Spain, Sweden, Switzerland, Thailan
- Date initiated
- 2016-07-28
- Date posted
- 2016-09-01
- Date terminated
- 2017-06-07
- Location
- Fort Worth, TX
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