MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-06 for ACRYSOF IQ TORIC SINGLEPIECE IOL SN6AT4 SN6AT4.245 manufactured by Alcon Laboratories Ireland Ltd..
[182287816]
A sample product was not returned for analysis. Complaint history and product history records were reviewed and documentation indicated the product met release criteria. Root cause has not been identified. There are no other complaints in the lot. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182287817]
A surgeon reported that after an intraocular lens (iol) implant procedure when the surgeon was doing a postoperative check, he noted a scratch on the iol. There was no impact on the patient and the lens remains implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612169-2020-00046 |
| MDR Report Key | 9677556 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2018-04-19 |
| Date Added to Maude | 2020-02-06 |
| 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 | 2020-02-06 |
| Model Number | SN6AT4 |
| Catalog Number | SN6AT4.245 |
| Lot Number | 21215127 |
| 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 | 2020-02-06 |