ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM Adverse Event — Malfunction (MDR 1119421-2020-00731)
ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM Adverse Event — Malfunction (MDR 1119421-2020-00731) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; Generic name: LENS, GUIDE, INTRAOCULAR; Manufacturer: ALCON R
| Device | ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM |
|---|---|
| Generic name | LENS, GUIDE, INTRAOCULAR |
| Manufacturer | ALCON RESEARCH, LLC - HUNTINGTON |
| Report number | 1119421-2020-00731 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN, HEALTH PROFESSIONAL |
| Narrative | EVALUATION 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). |
| Source | openFDA MAUDE (device adverse events) |
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