MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,other report with the FDA on 2015-06-11 for BIOTRUE MULTI-PURPOSE SOLUTION manufactured by Bausch & Lomb.
[5945287]
A claim was received from a law office reporting their client was diagnosed with bacterial keratitis after the use of a contact lens solution. The claim indicated the lenses were stored in the solution for almost a month before the client wore the lenses. Approximately after 4 hrs of wear, pt developed pain, irritation and cloudy vision. Accompanying medical records provided by the law office states pt inserted a pair of cosmetic contact lenses and experienced redness, pain, burning and blurriness in the right eye. Pt was diagnosed with bacterial keratitis and treated with antibiotics. After 2 wks of antibiotic therapy, patient's eye condition did not improve. The patient's medical records indicates pt was seen and treated for recurrent corneal erosion, unspecified keratitis, central cornea an ulcer and epithelial defect for the time period from (b)(6) 2012 through (b)(6) 2014. The hosp had cultures performed of the contact lens and lens case, it was positive for klebsiella and pseudomonas, fungus as well as penicillin species and mycobacterium. A corneal biopsy was performed and no fungi or acanthameba was seen on the pathology. During a follow-up visit, the hospital's impression was multi microbial corneal ulcer right eye and subsequent scarring and neovascularization, secondary from cosmetic contact lens use. A deep anterior lamellar keratoplasty (dalk) with possible conversion to penetrating keratoplasty (pk) of the right t eye was recommended by the doctor. A corneal transplant was performed on the right eye. The device and lot number has been requested from the law office.
Patient Sequence No: 1, Text Type: D, B5
[13352349]
The product involved in the event has not been returned and no lot information is available. Medical records received states the hospital's impression was multi microbial corneal ulcer right eye and subsequent scarring and neovascularization, secondary from cosmetic contact lens use. Based on all information, no casual factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[65039798]
A review of the lot batch records found all requirements were met. Based on all information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[65039799]
Additional information and product lot number were received from the law office. The claimant is still under treatment and has a stitch in her transplanted eye. The law office states the doctors are uncertain if the stitch will be removed. The product lot is expired.
Patient Sequence No: 1, Text Type: D, B5
[65042754]
Based on all information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[65042755]
Additional medical records dating from (b)(6) 2015 were received from the health care center. The records indicate patient had ongoing follow-up visits with the doctor for the eye condition associated with the event. It is noted that patient has dry eyes. The doctor discussed options with glasses and future opportunity for rgp contact lenses. At the patient's last visit on (b)(6) 2015, she was diagnosed with an unspecified ptosis of eyelid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1313525-2015-01565 |
| MDR Report Key | 4843727 |
| Report Source | 00,OTHER |
| Date Received | 2015-06-11 |
| Date of Report | 2015-05-22 |
| Date of Event | 2012-12-04 |
| Date Mfgr Received | 2015-11-16 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2015-06-16 |
| 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 | 3 |
| Manufacturer Contact | MS. SARUM OEUN |
| Manufacturer Street | 1400 NORTH GOODMAN STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853385091 |
| Manufacturer G1 | BAUSCH + LOMB |
| Manufacturer Street | 8507 PELHAM ROAD |
| Manufacturer City | GREENVILLE SC 296159598 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 296159598 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTRUE MULTI-PURPOSE SOLUTION |
| Generic Name | ACCESSORIES, SOLUTION, LENS CLEANER |
| Product Code | LYL |
| Date Received | 2015-06-11 |
| Lot Number | GF1112 |
| ID Number | NI |
| Device Expiration Date | 2012-12-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | ROCHESTER NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2015-06-11 |