MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-04-21 for BIOTRUE MULTI-PURPOSE SOLUTION manufactured by Bausch & Lomb.
[20972282]
As a result of a consumer complaint, retain samples of tank lot jk3573 were tested and confirmed to have been out of specification (undetectable) for one of the two disinfectants: polyquaternium-1 (pq-1). The pq-a specification is (b)(4). Pq-1 id testing did show pq-1 to be present. Due to the remaining 6 months of the 24 month shelf life for finished product filled from tank jk3573, the decision was made to recall the associated finished product. There is no health hazard concern as the other disinfectant was shown to be at the proper level and shown through additional laboratory testing to provide disinfectant coverage. There is an on-going investigation into the root cause for the out of specification result.
Patient Sequence No: 1, Text Type: D, B5
[21153207]
The returned sample was tested and found to eb out of specification for one of the two disinfectants; polyquaternium-1 (pq-1) was not detected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313525-2014-00005 |
| MDR Report Key | 3855772 |
| Report Source | 04 |
| Date Received | 2014-04-21 |
| Date of Report | 2014-04-14 |
| Date Mfgr Received | 2014-04-14 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2014-06-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 1400 NORTH GOODMAN ST. |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388549 |
| Manufacturer G1 | BAUSCH & LOMB, INC. |
| Manufacturer Street | 8507 PELHAM ROAD |
| Manufacturer City | GREENVILLE SC 29615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29615 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1032500-04/21/2014-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTRUE MULTI-PURPOSE SOLUTION |
| Generic Name | CONTACT LENS MULTI-PURPOSE SOLUTION |
| Product Code | LYL |
| Date Received | 2014-04-21 |
| Returned To Mfg | 2014-02-03 |
| Lot Number | GK2127 |
| Device Expiration Date | 2014-10-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | ROCHESTER NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-21 |