MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2016-11-15 for BIOTRUE MULTI-PURPOSE SOLUTION manufactured by Bausch + Lomb.
[59903498]
The complaint sample was returned for evaluation and the results of the chemical testing performed were within specifications. A review of the lot batch record and microbial testing of a retain sample concluded this product was formulated, manufactured and packaged according to local and global specifications. Based on information available, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[59903499]
Consumer's mother reported event for her (b)(6) old daughter who has been a contact lens user for a few years. Mother claimed there was a different smell when opening the package and that after using it for about 2 weeks the daughter developed redness and stinging in both eyes. After going to an ophthalmologist, the consumer provided the prescription information which indicated the doctor diagnosed keratoconjunctivitis, and the doctor prescribed zylet, tobrex, refresh and artelac. After about 2 days, the symptoms were reported to be resolved. When the product use was resumed, the symptoms were reported to return. After 2-3 days of treatment, the consumer was reported to be healthy and symptom-free with spectacles. Medical records associated with the medical visit were not available.
Patient Sequence No: 1, Text Type: D, B5
[68394111]
Chemical testing of a retain sample concluded this product was formulated, manufactured and packaged according to local and global specifications. Based on all information, no causal factors can be determined and no conclusion can be drawn. Correction to initial report: this product is not associated with a recall.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001313525-2016-00569 |
| MDR Report Key | 6102986 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2016-11-15 |
| Date of Report | 2016-06-20 |
| Date of Event | 2016-06-12 |
| Date Mfgr Received | 2016-06-20 |
| Device Manufacturer Date | 2015-07-16 |
| Date Added to Maude | 2016-11-15 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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-IOM S.P.A. |
| Manufacturer Street | VIA PASUBIO 34 20050 MACHERIO |
| Manufacturer City | MILAN 92618 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Remedial Action | RC |
| 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 | 2016-11-15 |
| Returned To Mfg | 2016-07-28 |
| Lot Number | MA0440 |
| ID Number | NI |
| Device Expiration Date | 2017-07-31 |
| 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 |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-15 |