MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-02-02 for EYE PROTECTION SHIELD 8888501219 manufactured by Alcon - Fort Worth.
[560381]
The facility reported that the dual eye shield was too loose, causing the lasik caps to be displaced in four cases; additional surgery required. Additional info has been requested. This pt is being reported under mfr. Report # 1610287-2007-00004. The other pts are being reported under mfr. Report #'s 1610287-2007-00002, 1610287-2007- 00003, 1610287-2007- 00005.
Patient Sequence No: 1, Text Type: D, B5
[7945101]
Product was not available for evaluation. The supplier of the eye protection shields has been notified of these events. Unable to determine root cause from this investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2007-00004 |
| MDR Report Key | 812189 |
| Report Source | 05 |
| Date Received | 2007-02-02 |
| Date of Report | 2007-01-05 |
| Date Mfgr Received | 2007-01-05 |
| Date Added to Maude | 2007-02-06 |
| 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 | 0 |
| Manufacturer Contact | MICHAEL BUENGER |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175516810 |
| Manufacturer G1 | ALCON LABORATORIES, INC. |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 76134209 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 76134 2099 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EYE PROTECTION SHIELD |
| Generic Name | EYE PROTECTION SHIELD |
| Product Code | HOY |
| Date Received | 2007-02-02 |
| Model Number | 8888501219 |
| Catalog Number | 8888501219 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 799672 |
| Manufacturer | ALCON - FORT WORTH |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 761342099 US |
| Baseline Brand Name | EYE PROTECTION SHIELD |
| Baseline Generic Name | EYE PROTECTION SHIELD |
| Baseline Model No | 8888501219 |
| Baseline Catalog No | 8888501219 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-02-02 |