MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED ULTRA (SAMFILCON A) CONTACT LENS LENSES, SOFT CONTACT, DAILY WEAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Corneal Scar (1793); Corneal Ulcer (1796); Dry Eye(s) (1814); Irritation (1941); Itching Sensation (1943); Pain (1994); Red Eye(s) (2038); Uveitis (2122); Loss of Vision (2139); Corneal Infiltrates (2231); Excessive Tear Production (2235)

Event Date 12/07/2018

Event Type  Injury  

Manufacturer Narrative

The product was discarded and the lot number is unknown. Additional medical information has been requested but not received. Based on all available information, no causal factors can be determined and no conclusion can be drawn.

Event Description

A doctor reported to a sales rep that a patient experienced redness, irritation, tearing and light sensitivity in both eyes and temporarily lost vision in their right eye after wearing contact lenses. The patient was seen by the doctor on (b)(6) 2018. After examination, a bulbar injection of the right eye and an anterior chamber reaction of 4 + cells + flare in the right eye were noted. The patient was diagnosed with unspecified acute and subacute iridocyclitis. The patient was advised to use a cold/warm compress, to temporarily suspend contact lens wear and was prescribed homatropine and pred forte to be used from (b)(6). The doctor indicated the likely cause of the event is anterior uveitis of unknown cause. The patient returned to the office on (b)(6) 2018 with continued pain and light sensitivity and elected to continue treatment with a different doctor. It was also reported the patient was under treatment of fml (fluorometholone ophthalmic suspension), tropicamide. 5% and phenylephrine 2. 5%. It is uncertain which doctor prescribed these medications. Additional information was obtained from the consumer. The consumer reported that they have recovered and are currently not wearing contact lenses. The consumer visited multiple doctors including an urgent care and emergency room. It was confirmed that one of the doctors was a glaucoma specialist who confirmed that the patient was not seen by their office for the symptoms experienced after wearing the contact lenses. Additional medical information has been requested from the remaining doctors but has not yet been received.

• Brand Name: ULTRA (SAMFILCON A) CONTACT LENS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED; 1400 north goodman street; rochester NY 14609
• Manufacturer Contact: jennifer gamet ; 1400 north goodman street; rochester, NY 14609 ; 5853386853
• MDR Report Key: 8499690
• MDR Text Key: 141470144
• Report Number: 0001313525-2019-00061
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K131208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 04/10/2019 Patient Sequence Number: 1

Treatment

OPTIFREE REPLENISH SOLUTION