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..
[415401]
A patient developed acanthamoeba keratitis during orthokeratology for myopic reduction. Patient was wearing overnight rigid gas permeable (oprifocon a) reverse geometry contact lenses when she developed discomfort in the right eye. The discomfort progressed over one month despite antibacterial and coirticosteroid eye drops. At referral, patient presented with hand motions vision and a ring-shapeed stromal infiltrate. A corneal biopsy revealed amoebic cysts by histopathological evaluation. Acanthameoba species were isolated on buffered charcoal-yeast extract agar from corneal scrapings and from the contact lens. After six months of topical antiprotozoal therapy, visual acuity had improved. One year later, penetrating keratoplasty was performed. The corneal button was thinned and scarred but had no observable cysts. Postkeratoplasty visual acuity improved to 20/20.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1313525-2006-00004 |
| MDR Report Key | 667057 |
| 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 | 656425 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Manufacturer Address | 1400 NORTH GOODMAN ST. ROCHESTER NY 14609 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-01-23 |