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 2016-11-18 for BIOTRUE MULTI-PURPOSE SOLUTION manufactured by Bausch & Lomb Incorporated.
[60333962]
The complaint sample was returned and is currently pending evaluation. A review of the lot device history records is ongoing. Based on available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[60333963]
Consumer reported experiencing pain, blurred vision, and redness upon initial use of product. Consumer reported visiting emergency room and being diagnosed with chemical conjunctivitis in both eyes. Consumer was prescribed tobramycin. 3% ophthalmic solution and instructed to follow-up with her eye care professional. The consumer has not provided update on condition and has not provided indication of follow-up. Medical records have been requested but have not been received.
Patient Sequence No: 1, Text Type: D, B5
[62728342]
Treating doctor reported that the complaint device caused or contributed to the event, however, the complaint sample was returned for evaluation and the results of the testing performed were all within specification. Additionally, a review of the lot batch record concluded that this product was formulated and manufactured according to local and global specifications. Based on available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[62728343]
Since the initial report dated 18-nov-2016, information obtained from the healthcare provider indicates the patient was diagnosed with bilateral chemical conjunctivitis. Per treating doctor, patient visited emergency department with bilateral eye injection and tearing. Patient stated that her symptoms began after using the contact lens solution in question. Patient was prescribed erythromycin ophthalmic ointment and tobramycin eye drops. Doctor reported patient is compliant with lens wear and care. The doctor reported that there was no permanent damage and noted that the patient is recovered. While medical documentation indicates patient is recovered, patient reports her eyes to still be red and dry.
Patient Sequence No: 1, Text Type: D, B5
[72905821]
Based on available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[72905822]
Additional information obtained indicates that the consumer followed-up at an eye clinic two days following her visit to the emergency room. Optometrist who saw patient at eye clinic informed that the patient was seen in the emergency room for symptoms of ocular burning, redness, discharge, and blurred vision. Patient was treated and instructed to follow-up with the clinic. At time of her follow-up visit, the patient presented with burning, discharge, redness, and blurred vision. Optometrist diagnosed chemical conjunctivitis. It was noted that the cornea was not involved and that the examination was normal. Patient? S eyes appeared stable and optometrist recommended patient discontinue the medication provided by the emergency room. Optometrist noted that the patient was convinced that her symptoms were secondary to the contact lens solution in question and stated that the timing was compelling. Patient was then seen two weeks later for a comprehensive eye examination and there were no residual effects. Four months later, consumer visited an alternate eye clinic. Information obtained from this clinic indicates that the patient was seen with symptoms of floaters in both eyes. Cornea was not involved. Doctor diagnosed bilateral vitreous degeneration and bilateral myopia. Patient was only seen once at this clinic and was not provided with any medical intervention. Doctor opined that the likely cause of the event was age related vitreous degeneration. Clinic also noted that the patient has a history of vitreous degeneration and myopia. Both doctors indicated that the event was not considered life threatening, did not result in permanent damage to a body structure, and did not necessitate medical/surgical intervention in order to preclude permanent damage to a body structure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2016-00609 |
| MDR Report Key | 6112785 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2016-11-18 |
| Date of Report | 2016-10-19 |
| Date of Event | 2016-10-19 |
| Date Mfgr Received | 2017-03-31 |
| Device Manufacturer Date | 2016-06-20 |
| Date Added to Maude | 2016-11-18 |
| 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 | BIOTRUE MULTI-PURPOSE SOLUTION |
| Generic Name | ACCESSORIES, SOLUTION, CLEANERS FOR LENSES |
| Product Code | LYL |
| Date Received | 2016-11-18 |
| Returned To Mfg | 2016-11-01 |
| Lot Number | GF16073 |
| ID Number | NI |
| Device Expiration Date | 2018-06-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2016-11-18 |