MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-25 for FLEXIBLE IRIS RETRACTOR 5 IN PKG 611.74 GR 611.74 manufactured by Alcon Grieshaber, Ltd..
[18263674]
A doctor reported that during cortex removal, an anterior capsule tear was noted at the site of a flexible iris retractor. No patient impact was experienced. Additional info has been requested.
Patient Sequence No: 1, Text Type: D, B5
[18559210]
No sample or lot number info has been received by mfr for evaluation. As the affected lot number is not known, the device history record could not be reviewed. The mfr performs a 100% final inspection for this product. 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 info becomes available. Additional info has been requested, but none has been received. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003398873-2015-00003 |
| MDR Report Key | 4548677 |
| Report Source | 05 |
| Date Received | 2015-02-25 |
| Date of Report | 2015-01-27 |
| Date of Event | 2015-01-26 |
| Date Mfgr Received | 2015-01-27 |
| Date Added to Maude | 2015-02-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JANET MORAN |
| Manufacturer Street | 6201 SOUTH FREEWAY, R3-48 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152742 |
| Manufacturer G1 | ALCON GRIESHABER, LTD. |
| Manufacturer Street | WINKELRIEDSTRASSE 52 |
| Manufacturer City | SCHAFFHAUSEN CH-8203 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-8203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIBLE IRIS RETRACTOR 5 IN PKG |
| Generic Name | CLIP, IRIS RETRACTORS |
| Product Code | HOC |
| Date Received | 2015-02-25 |
| Model Number | 611.74 |
| Catalog Number | GR 611.74 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON GRIESHABER, LTD. |
| Manufacturer Address | WINKELRIEDSTRASSE 52 SCHAFFHAUSEN CH-8203 SZ CH-8203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-02-25 |