MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2001-07-26 for BOSTON EQUALENS II manufactured by Bausch & Lomb, Inc..
[228802]
The patient had undergone a corneal transplant to correct vision loss due to a corneal scar caused by herpes keratitis. A scleral contact lens was prescribed post surgically and after approximately three years of lens wear the patient developed a pseudomonas corneal ulcer in that eye. The ulcer was treated and contact lens wear was resumed two months later. Patient's vision with the contact lens prior to the incident was 20/40 and patient's vision after resuming contact lens wear had returned to 20/60. There is a remaining corneal scar.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1313525-2001-00004 |
| MDR Report Key | 343950 |
| Report Source | 01,05 |
| Date Received | 2001-07-26 |
| Date of Report | 2001-06-25 |
| Date of Event | 2001-04-19 |
| Report Date | 2001-06-25 |
| Date Mfgr Received | 2001-06-25 |
| Device Manufacturer Date | 2000-02-01 |
| Date Added to Maude | 2001-07-31 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL SANTALUCIA, VICE PRES. |
| Manufacturer Street | 1400 N. GOODMAN ST. |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 7163388731 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOSTON EQUALENS II |
| Generic Name | SCLERAL CONTACT LENS |
| Product Code | MWL |
| Date Received | 2001-07-26 |
| Returned To Mfg | 2001-07-12 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 0026PTC006 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 3.5 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 333286 |
| 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; 3. Deathisabilit | 2001-07-26 |