MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,08 report with the FDA on 2007-03-23 for BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS manufactured by Bausch & Lomb.
[606074]
A distributor reports that an eyecare practitioner fit a pt with a trial pair of lenses for overnight. The pt changed the water in her fish tank that night and accidentally splashed water into her eyes. The following day, she presented to the hcp with complaints of discomfort in one eye and she was told to discontinue use of the contact lenses. The discomfort persisted and the pt presented to her general practitioner who prescribed tetracycline application to her eyes. The condition worsened the following day and the pt presented to the eye hosp. The ophthalmologist examined the eye tissue and inspected the contact lenses. The pt was diagnosed with a fungal infection. It was reported that the event "has nothing to do with" the contact lenses. The pt is now under close observation and if no improvement, a corneal transplant may be required.
Patient Sequence No: 1, Text Type: D, B5
[7869201]
No product was returned and no lot number info was provided. The pt changed the water in her fish tank and reported splashing water into her eyes the night prior to the onset. It was reported the event "has nothing to do with" the lenses.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313525-2007-00059 |
| MDR Report Key | 830738 |
| Report Source | 00,01,05,08 |
| Date Received | 2007-03-23 |
| Date of Report | 2007-03-12 |
| Date of Event | 2007-03-01 |
| Date Mfgr Received | 2007-03-12 |
| Date Added to Maude | 2007-03-27 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | TES PROUD |
| Manufacturer Street | 1400 N. GOODMAN ST |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388549 |
| Manufacturer G1 | BAUSCH & LOMB WILMINGTON |
| Manufacturer Street | 100 RESEARCH DR |
| Manufacturer City | WILMINGTON MA 01887440 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01887 4406 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS |
| Generic Name | GAS PERMEABLE CONTACT LENS |
| Product Code | MUW |
| Date Received | 2007-03-23 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 818087 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | 1400 NORTH GOODMAN ST. ROCHESTER NY 14609 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-03-23 |