• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAUSCH & LOMB INCORPORATED ULTRA (SAMFILCON A) CONTACT LENS LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameULTRA (SAMFILCON A) CONTACT LENS
Type of DeviceLENSES, 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 Key8499678
MDR Text Key141480348
Report Number0001313525-2019-00060
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K131208
Number of Events Reported1
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 Received04/10/2019
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
-
-