MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-11-29 for SOFLENS DAILY DISPOSABLE CONTACT LENS manufactured by Bausch & Lomb Incorporated.
[128791996]
A lot number has been requested but not provided. The lens has been discarded by the patient. Additional medical information was requested; however, has not been received. This report is for the right eye, -4. 25 power. 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
[128791997]
A consumer reported that on (b)(6) the consumer inserted a new pair of lenses and experienced no eye discomfort while wearing the lenses. Upon removal of the lenses the consumer experienced stinging in their right eye. At this time they only removed half of a lens from the right eye and had continued eye pain. On the next day the consumer visited a hospital with complaints of eye pain in both eyes. The doctor removed half of a contact lens in the consumer? S right eye and diagnosed them with bilateral conjunctivitis. They were prescribed an eye drop; however they do not recall the name of this eye drop. The consumer experienced aggravated eye pain in both eyes and returned to the hospital on (b)(6). The doctor removed another piece of contact lens; it is unclear which eye the lens was removed from. They were prescribed levofloxacin eye drops and "clopidine" eye drops at one drop 3 times daily for both eyes until (b)(6). On (b)(6) the consumer continued to have eye pain and visited the emergency room. They were diagnosed with conjunctivitis of both eyes again. They returned to the hospital on (b)(6) and were prescribed sodium hyaluronate eye drops to use daily. On (b)(6) the consumer visited the hospital again due to continued pain. They were diagnosed with corneal exfoliation of the upper eyelid on the right eye and bilateral conjunctivitis. They were prescribed fluorometholone eye drops, one drop 3 times a day both eyes and ganciclovir eye gel at night. On (b)(6) the consumer right eye recovered; however, they continued to have left eye pain. They visited the hospital on (b)(6) and they were prescribed fluorometholone eye drops and ganciclovir eye gel. They reported they would return to the hospital for a checkup. Medical records and doctors contact information has been requested, but not received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2018-00219 |
| MDR Report Key | 8116696 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-11-29 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-09-28 |
| Date Added to Maude | 2018-11-29 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFLENS DAILY DISPOSABLE CONTACT LENS |
| Generic Name | LENS, CONTACT, DISPOSABLE |
| Product Code | MVN |
| Date Received | 2018-11-29 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB INCORPORATED |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-29 |