MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-11 for ACRYSOF IQ TORIC SINGLEPIECE IOL SN6AT4 SN6AT4.200 manufactured by Alcon Laboratories Ireland Ltd..
[185719544]
The product was returned for analysis and the reported damage was observed. Additional observations were as follows: iol returned pressed down into well area of iol case base, resulting in deformation of the iol. Solution is dried on both surfaces of the optic and haptics. One haptic is adhered to the optic surface with solution. The optic is cracked/fractured and scratched/marked-rejectable with loose fibers & particulate. We are unable to determine the root cause for the reported complaint "faulty lens". The returned iol shows evidence of possible handling by the customer due to the presence of solution dried on both surfaces of the optic and haptics. In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens damage would not meet our current release criteria. Based on these investigation findings, we are unable to verify if the iol contributed to the event. All product and batch history records are quality reviewed prior to product release. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185719545]
A health professional reported that an intraocular lens was faulty. The timing of the event and patient impact are unknown. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612169-2020-00097 |
| MDR Report Key | 9818078 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2018-01-13 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2016-01-28 |
| Date Added to Maude | 2020-03-11 |
| 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 | 2020-03-11 |
| Returned To Mfg | 2020-01-30 |
| Model Number | SN6AT4 |
| Catalog Number | SN6AT4.200 |
| Lot Number | 21152218 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-11 |