MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03 report with the FDA on 2012-10-31 for UNKNOWN RIGID GAS PERMEABLE CONTACT LENS manufactured by Bausch & Lomb.
[20228889]
The attached article reports a study aimed to determine the prevalence of contact lens related complications in a tertiary eye care center in (b)(6). The article reports complications associated with various contact lens products. Table 2 summarizes the varied complications. Table 4 summarizes the complications by lens material. However, the article and table do not provide detail to determine the specific complications associated with the identified lens materials. The author of the article was contacted for additional info regarding the cases of complications and responded that the cases were not categorized by material or brand and there is no further info. Table 2 indicates there were eight cases of microbial keratitis. Of the eight cases, seven were associated with the soft contact lens materials, and one pt was an rgp wearer. It is not known if the pts were wearing a bausch and lomb lens. However, the possibility of an event being associated with a bausch and lomb material cannot be ruled out. Therefore, the eight infectious keratitis cases are being reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1313525-2012-00037 |
| MDR Report Key | 2820630 |
| Report Source | 01,03 |
| Date Received | 2012-10-31 |
| Date of Report | 2012-10-02 |
| Date Mfgr Received | 2012-10-02 |
| Date Added to Maude | 2012-11-07 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARLENE MARTRANO |
| Manufacturer Street | 1400 NORTH GOODMAN ST. |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388995 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN RIGID GAS PERMEABLE CONTACT LENS |
| Generic Name | NONE |
| Product Code | MUW |
| Date Received | 2012-10-31 |
| 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. Required No Informationntervention | 2012-10-31 |