MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-05-13 for ACRYSOF SN60AT NA manufactured by Alcon Laboratories, Inc./huntington.
[397568]
A surgeon reports that during intraocular lens (iol) implant surgery, he noted a cracked lens after insertion. The incision was enlarged to facilitate removal and replacement of the iol. Additional information had been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119421-2005-00178 |
| MDR Report Key | 602641 |
| Report Source | 05 |
| Date Received | 2005-05-13 |
| Date of Report | 2005-04-13 |
| Date Mfgr Received | 2005-04-13 |
| Device Manufacturer Date | 2003-11-01 |
| Date Added to Maude | 2005-05-17 |
| 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 | 0 |
| Manufacturer Contact | CATHERINE GLOBE |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 761342099 |
| Manufacturer Country | US |
| Manufacturer Postal | 761342099 |
| Manufacturer Phone | 8175516816 |
| Manufacturer G1 | ALCON LABORATORIES, INC./HUNTINGTON |
| Manufacturer Street | 6065 KYLE LANE |
| Manufacturer City | HUNGTINGTON 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 |
| Generic Name | INTRAOCULAR LENS |
| Product Code | HDL |
| Date Received | 2005-05-13 |
| Returned To Mfg | 2005-03-17 |
| Model Number | SN60AT |
| Catalog Number | NA |
| Lot Number | 803010 |
| ID Number | NA |
| Device Expiration Date | 2008-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 592474 |
| Manufacturer | ALCON LABORATORIES, INC./HUNTINGTON |
| Manufacturer Address | 6065 KYLE LN. HUNTINGTON WV 25702 US |
| Baseline Brand Name | ACRYSOF |
| Baseline Generic Name | INTRAOCULAR LENS |
| Baseline Model No | SN60AT |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-05-13 |