MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2017-04-14 for BOSTON ADVANCE CONDITIONING SOLUTION manufactured by Bausch & Lomb Incorporated.
[72838415]
The complaint sample was not returned for evaluation. Consumer revealed that the hydrogen peroxide system in use was expired; also, the consumer was unwilling to provide lot information associated with the conditioning solution. Additional medical information has been requested but has not been received. It should be noted that eyes with keratoconus may develop severe corneal scarring or become unable to tolerate a contact lens as a normal course of the condition (national eye institute). Based on available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[72838416]
A consumer reported being diagnosed with a corneal ulcer in her right eye. The consumer wears a scleral lens to correct keratoconus and reported that she soaks the lens daily in the conditioning solution and that she cleans and disinfects with the hydrogen peroxide system weekly. A representative at the practice where the consumer was seen reported that in addition to keratoconus, the patient also has a history of corneal infiltrates, glaucoma, and dry eyes. Upon her initial visit relevant to this event, the office noted that the patient presented with a red eye and with complaints of a burning sensation. The eye doctor diagnosed a non-infectious ulcer in the central 6mm of the cornea of the right eye and prescribed an antibiotic (ofloxacin) and corticosteroid (prednisolone acetate). The doctor noted that the lenses were heavily coated with protein and recommended a deep cleaning. On a follow-up visit two days later, the patient returned with lessening symptoms. Punctate keratitis in the right eye was noted. Five days later, the patient followed-up once again and the office representative indicated that the patient? S condition had resolved. Patient is recovered. Office representative stated that there was no permanent decrease in visual acuity. No further follow-ups relevant to this event have been scheduled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2017-02410 |
| MDR Report Key | 6494075 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2017-04-14 |
| Date of Report | 2017-04-03 |
| Date of Event | 2017-03-27 |
| Date Mfgr Received | 2017-04-03 |
| Date Added to Maude | 2017-04-14 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SHARON SPENCER |
| Manufacturer Street | 50 TECHNOLOGY DRIVE WEST |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9493985698 |
| Manufacturer G1 | BAUSCH + LOMB |
| Manufacturer Street | 8507 PELHAM ROAD |
| Manufacturer City | GREENVILLE SC 29615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOSTON ADVANCE CONDITIONING SOLUTION |
| Generic Name | ACCESSORIES, SOLUTION, CLEANERS FOR LENSES |
| Product Code | LYL |
| Date Received | 2017-04-14 |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB INCORPORATED |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-14 |