MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-01-31 for SOFLENS DAILY DISPOSABLE CONTACT LENS manufactured by Bausch & Lomb Incorporated.
[177268134]
The device has not been returned for evaluation. It is unknown at this time if the same lens had been worn for 3 days. A review of the device history records found no anomalies and all results for lens and solution met the acceptance criteria. Based on all available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[177268135]
Hpra reported a doctor submitted a medical device adverse incident report. The doctor reported that a patient developed proteolytic keratitis after contact lens wear for 3 days, resulting in loss of vision and corneal scarring. Microbial tests were negative for pseudomonas/acanthamoeba infection. Additional medical information has been requested, but not yet received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2020-00018 |
| MDR Report Key | 9653699 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-03 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-03 |
| Date Added to Maude | 2020-01-31 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JENNIFER GAMET |
| Manufacturer Street | 1400 NORTH GOODMAN STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853386853 |
| Manufacturer G1 | BAUSCH + LOMB |
| Manufacturer Street | UNIT 424/425, CORK ROAD INDUSTRIAL ESTATE |
| Manufacturer City | WATERFORD |
| Manufacturer Country | EI |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFLENS DAILY DISPOSABLE CONTACT LENS |
| Generic Name | LENS, CONTACT, DISPOSABLE |
| Product Code | MVN |
| Date Received | 2020-01-31 |
| Lot Number | W62013797 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB INCORPORATED |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Product Code | --- |
| Date Received | 2020-01-31 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-31 |