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 2020-02-05 for ACRYSOF TORIC IOL ASKU manufactured by Alcon Research, Llc - Huntington.
[182171547]
Evaluation summary: the product was not returned for analysis. The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation. The product investigation could not identify a root cause. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182171548]
A physician reported that during multiple cataract surgeries with intraocular lens (iol) implantations, some filaments appear to be attached to the lens optics, forcing maneuvers to remove these filaments could complicate the course of the surgeries. The physician said that they are a part of the lenses and has ruled out that these filaments may be introduced to the lenses in some way during surgery. There are three medical device reports associated with the report of multiple events with filaments are iol's. This report is for multiple lenses with no specific event dates or patient identifiers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119421-2020-00187 |
| MDR Report Key | 9673114 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-02-05 |
| 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. JASON MICHAELIDES |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686438 |
| 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 TORIC IOL |
| Generic Name | LENS, INTRAOCULAR, TORIC OPTICS |
| Product Code | MJP |
| Date Received | 2020-02-05 |
| Model Number | ASKU |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-02-05 |