MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-25 for PLASTIC SPECTACLE LENS manufactured by Rosin Optical Co..
[15275]
Rptr received the pair of glasses via ups overnight on 5/13/95, put them on and adjusted them on her nose by touching them at the temple. She said that one of the lenses partially shattered and a "v" shaped shard flew in to her left eye, piercing her cornea travelling across it and injuring her pupil. She had her eye doctor remove the shard, and she has permanently lost her sight in the eye. She stated that she reported the incident to the firm and they told her they were not going to report it to the fda.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000690 |
| MDR Report Key | 24954 |
| Date Received | 1995-08-25 |
| Date of Report | 1995-06-02 |
| Date of Event | 1995-05-13 |
| Date Added to Maude | 1995-08-25 |
| 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 | PLASTIC SPECTACLE LENS |
| Generic Name | SPECTACLE LENS |
| Product Code | HQY |
| Date Received | 1995-08-25 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 25385 |
| Manufacturer | ROSIN OPTICAL CO. |
| Manufacturer Address | 6233 CERMARK RD BERWYN IL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-08-25 |