MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for SOFLENS 38 SOFT CONTACT LENS 6 CT BOX -6.50, -5.75 BC8.4, D14.0 UPC 785810242672 manufactured by Bausch & Lomb Incorporated.
[184241180]
Ordered 2 boxes of contact lenses from contactlensking. Com, site switches to clk. Com which is not the norm. Upon using lenses, i was unable to see. I thought there was an error in my prescription. Now i believe the lenses are defective. Today i opened a new pair and noticed a large chip on the edge of one of the lenses and on the other the "s" logo was backwards / reversed and not in usual spot. Both boxes also state made in (b)(6). Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093811 |
| MDR Report Key | 9847945 |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-13 |
| Date of Event | 2019-03-15 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFLENS 38 SOFT CONTACT LENS 6 CT BOX |
| Generic Name | LENSES, SOFT CONTACT, DAILY WEAR |
| Product Code | LPL |
| Date Received | 2020-03-17 |
| Model Number | -6.50, -5.75 BC8.4, D14.0 |
| Catalog Number | UPC 785810242672 |
| Lot Number | Y91900070 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB INCORPORATED |
| Brand Name | SOFLENS 38 SOFT CONTACT LENS 6 CT BOX |
| Generic Name | LENSES, SOFT CONTACT, DAILY WEAR |
| Product Code | LPL |
| Date Received | 2020-03-17 |
| Model Number | -6.50, -5.75 BC8.4, D14.0 |
| Catalog Number | UPC 785810242672 |
| Lot Number | Y91901337 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB INCORPORATED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Deathisabilit | 2020-03-17 |