MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2006-01-23 for BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS manufactured by Bausch & Lomb, Inc..
[415516]
Patient who had been undergoing orthokeratology for 2 years presented to walk-in clinic with 1 day history of photophobia, pain and reduced vision od. Patient was diagnosed with a corneal abrasion; eye was patched overnight with gentamycin. The next day, patient was referred to an ophthalmologist. Upon exam, best corrected visual acuity was light perception o. D. And 20/80 o. S. A well-centered orthokeratology contact lens was persent in the o. D. Removal of the lens revealed a central corneal ulcer associated with a purulent conjunctivitis. Anterior chamber details were obscured by the corneal infiltration. Corneal scrapings were obtained and showed gram-negative bacillus. Patient was admitted to the hospital with presumed diagnosis of pseudomonas keratitis. After a week of treatment, pain was diminished, the epithelial defect nearly resolved, and medications tapered. However, the visual acuity was only hand motions. Over the next 2 months, improvement continued, medications tapered and the epithelial defect healed. At last visit, 6 months later, best-corrected visual acuity was 20/80, consistent with a central corneal scar.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1313525-2006-00005 |
| MDR Report Key | 667074 |
| Report Source | 03,05 |
| Date Received | 2006-01-23 |
| Date of Report | 2005-12-28 |
| Date Mfgr Received | 2005-12-28 |
| Date Added to Maude | 2006-01-26 |
| 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 SANTALUCIA, VICE PRES. |
| Manufacturer Street | 1400 N. GOODMAN STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388731 |
| Manufacturer G1 | BAUSCH & LOMB WILMINGTON |
| Manufacturer Street | 100 RESEARCH DRIVE |
| 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 | 2006-01-23 |
| 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 | 656442 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Manufacturer Address | 1400 NORTH GOODMAN ST. ROCHESTER NY 14609 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2006-01-23 |