MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-28 for FLUOROPERM 60 manufactured by E & E Optics.
[11067]
On 9/93 and 1/6/95, rptr's gas permeable contact lens crumbled in her hand during normal cleaning procedure. (right eye) her concern is the potential for serious injury should the lens crumble while in the eye. There is conflicting data as to the thickness of these lenses. 1/12/95 measurements - center thickness of lens. Right eye -. 17 mm. Left eye -. 17 mm. 2/2/95 measurement - center thickness of lens. Right eye -. 15 mm. Left eye -. 17 mm. On both occasions of breakage, the lens was slightly one year old. (also see 1005270. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1005271 |
| MDR Report Key | 20046 |
| Date Received | 1995-02-28 |
| Date of Report | 1995-02-12 |
| Date of Event | 1995-01-06 |
| Date Added to Maude | 1995-03-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLUOROPERM 60 |
| Generic Name | GAS PERMEABLE CONTACT LENS |
| Product Code | HPX |
| Date Received | 1995-02-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19940 |
| Manufacturer | E & E OPTICS |
| Manufacturer Address | VAN NUYS CA 91411 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-02-28 |