MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-26 for ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM AU00T0 NA manufactured by Alcon Research, Llc - Huntington.
[181318444]
The device was received by a company representative and is in transit to the manufacturing site for investigation. Complaint history and product history records were reviewed and documentation indicated the product met release criteria. Investigation including root cause analysis will be completed. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. There are no other complaints in the lot. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[181318445]
A doctor reported that during an intraocular lens (iol) implant procedure, a haptic on the iol broke in the injector. There was no patient contact with the product, but the patient was left aphakic with plans to return to surgery in the future to implant an iol. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119421-2020-00324 |
| MDR Report Key | 9759126 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-26 |
| Date of Report | 2020-04-03 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-04-01 |
| Device Manufacturer Date | 2019-08-30 |
| Date Added to Maude | 2020-02-26 |
| 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 | 2020-02-26 |
| Model Number | AU00T0 |
| Catalog Number | NA |
| Lot Number | 12738847 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Other | 2020-02-26 |