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ACRYSOF IQ NATURAL SINGLEPIECE IOL Adverse Event — Injury (MDR 9612169-2020-00135)

ACRYSOF IQ NATURAL SINGLEPIECE IOL Adverse Event — Injury (MDR 9612169-2020-00135) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ACRYSOF IQ NATURAL SINGLEPIECE IOL; Generic name: INTRAOCULAR LENS; Manufacturer: ALCON LABORATORIES IRELAND LTD..

DeviceACRYSOF IQ NATURAL SINGLEPIECE IOL
Generic nameINTRAOCULAR LENS
ManufacturerALCON LABORATORIES IRELAND LTD.
Report number9612169-2020-00135
Event typeInjury
Product problemN
Date received2020-04-28
Report sourceFOREIGN, HEALTH PROFESSIONAL
NarrativeEVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THIS REPORT WAS ORIGINALLY FILED AS MFG. REPORT NUM. 1119421-2018-01488. THE MANUFACTURER INTERNAL R
SourceopenFDA MAUDE (device adverse events)

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