MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-28 for ACRYSOF IQ TORIC SINGLEPIECE IOL SN6AT3 SN6AT3.135 manufactured by Alcon Laboratories Ireland Ltd..
[184673686]
Evaluation summary: 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. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184673687]
A customer reported an intraocular lens (iol) was torn. The procedure was completed with a backup lens. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612169-2020-00073 |
| MDR Report Key | 9770986 |
| Report Source | OTHER |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2019-09-30 |
| Date Added to Maude | 2020-02-28 |
| 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 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 | 2020-02-28 |
| Model Number | SN6AT3 |
| Catalog Number | SN6AT3.135 |
| Lot Number | 21253290 |
| 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 | 2020-02-28 |