MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-05 for ACRYSOF IQ TORIC SINGLEPIECE IOL SN6AT3 SN6AT3.215 manufactured by Alcon Laboratories Ireland Ltd..
[182142148]
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).
Patient Sequence No: 1, Text Type: N, H10
[182142149]
A patient reported that following an intraocular lens (iol) implant procedure, the doctor wants to redo the surgery due to the lens clouding. Additional information was provided by the consumer, who reported that the first week while healing seemed ok. After that the vision started to blur. The problem has not resolved. Approximately one month after the implantation, the patient was told that the lens was cloudy and was told that they wanted her to pay for a yag laser capsulotomy which she feels is not her problem. She thinks the lens is defective.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612169-2020-00042 |
| MDR Report Key | 9671165 |
| Report Source | CONSUMER |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date Mfgr Received | 2020-01-12 |
| Device Manufacturer Date | 2019-02-07 |
| 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 LABORATORIES IRELAND LTD. |
| Manufacturer Street | CORK BUSINESS&TECHNOLOGY PARK MODEL FARM ROAD |
| Manufacturer City | CORK 00000 |
| Manufacturer Country | EI |
| Manufacturer Postal Code | 00000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACRYSOF IQ TORIC SINGLEPIECE IOL |
| Generic Name | LENS, INTRAOCULAR, TORIC OPTICS |
| Product Code | MJP |
| Date Received | 2020-02-05 |
| Model Number | SN6AT3 |
| Catalog Number | SN6AT3.215 |
| Lot Number | 21238310 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON LABORATORIES IRELAND LTD. |
| Manufacturer Address | CORK BUSINESS&TECHNOLOGY PARK MODEL FARM ROAD CORK 00000 EI 00000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |