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 2018-03-30 for BOSTON SIMPLUS MULTI-ACTION SOLUTION manufactured by Bausch + Lomb.
[103967403]
The ph of the solution evaluated by the hospital was reported to be 9. The complaint sample was not returned for evaluation. The ph for boston simplus is between 6. 5-7. 7. A review of the manufacturing records and testing of a retain sample of the reported lot found the product met all acceptance criteria at the time of manufacture and distribution. Based on reported confusion regarding product usage, the difference in product ph and hospital reported ph, the lack of returned product for evaluation, and the retain test which demonstrated the product met acceptance criteria, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[103967404]
Consumer reported severe pain when inserting the gas permeable contact lens for the right eye. The consumer reported that she had difficulty removing the lens. Following removal, the consumer washed the eye with water. Since there was no relief, the consumer sought medical attention. Hospital medical records indicated the patient thought the solution was her eye drops and soaked the lens in the solution prior to putting in the eye. The records indicated that the ph of the eye and the solution was 9, and a saline irrigation was administered. Examination observed a 0. 5 cm by 0. 5 cm corneal abrasion over the pupil. The consumer reported seeing a specialist who carried out further treatment and applied an eye patch. Consumer reported wearing the eye patch for three days. Doctor reported that consumer? S sight had restored.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2016-00568 |
| MDR Report Key | 7385706 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2018-03-30 |
| Date of Report | 2016-04-18 |
| Date of Event | 2016-03-27 |
| Date Mfgr Received | 2016-04-18 |
| Device Manufacturer Date | 2015-02-18 |
| Date Added to Maude | 2018-03-30 |
| 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. TES PROUD |
| Manufacturer Street | 1400 NORTH GOODMAN |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388549 |
| Manufacturer G1 | BAUSCH + LOMB-IOM S.P.A. |
| Manufacturer Street | VIA PASUBIO 34 20050 MACHERIO |
| Manufacturer City | MILAN, ITALY 20846 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 20846 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOSTON SIMPLUS MULTI-ACTION SOLUTION |
| Generic Name | PRODUCTS, CONTACT LENS CARE, RIGID GAS PERMEABLE |
| Product Code | MRC |
| Date Received | 2018-03-30 |
| Lot Number | BF091.1 |
| ID Number | NI |
| Device Expiration Date | 2017-02-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-03-30 |