MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-03-02 for ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM AU00T0 NA manufactured by Alcon Research, Llc - Huntington.
[184731681]
Evaluation summary: the product was returned for analysis. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. There have been no other complaints reported in the lot number. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184731682]
A facility representative returned an intraocular lens (iol) as faulty. It is unknown if the case concerns a patient. No further information is expected as no permission to follow up was received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119421-2020-00346 |
| MDR Report Key | 9774390 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2018-02-21 |
| Date Added to Maude | 2020-03-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JONATHAN SCHLECH |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514979 |
| Manufacturer G1 | ALCON RESEARCH, LLC - HUNTINGTON |
| Manufacturer Street | 6065 KYLE LANE |
| Manufacturer City | HUNTINGTON WV 25702 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 25702 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM |
| Generic Name | LENS, GUIDE, INTRAOCULAR |
| Product Code | KYB |
| Date Received | 2020-03-02 |
| Returned To Mfg | 2020-02-19 |
| Model Number | AU00T0 |
| Catalog Number | NA |
| Lot Number | 12596842 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LLC - HUNTINGTON |
| Manufacturer Address | 6065 KYLE LANE HUNTINGTON WV 25702 US 25702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-02 |