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

MAUDE Adverse Event Report: BAUSCH AND LOMB INC. PUREVISION MULTIFOCAL (BASILDON A) CONTACT LENS

  • 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 AND LOMB INC. PUREVISION MULTIFOCAL (BASILDON A) CONTACT LENS Back to Search Results
Lot Number R58536053
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Ulcer (1796); Pain (1994); Phototoxicity (2165); Fungal Infection (2419)
Event Date 01/02/2017
Event Type  Injury  
Event Description
Pain in eye with bausch and lomb purevision contact lens use. Sought specialist care and treatment, but symptoms progressed rapidly, infection started that was treated aggressively and cultured. On day 10 traveled to specialty eye hospital for emergent care. Day 12 received preliminary results of fungal infection. Disability for upwards of 3 weeks thus far due to pain, extreme photosensitivity, and hourly treatment. Large corneal ulcer, reporting months of treatment and likely cornea transplant amongst other treatments and procedures to correct/treat, if able.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePUREVISION MULTIFOCAL (BASILDON A)
Type of DeviceCONTACT LENS
Manufacturer (Section D)
BAUSCH AND LOMB INC.
MDR Report Key6278907
MDR Text Key65940945
Report NumberMW5067448
Device Sequence Number1
Product Code LPL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/25/2018
Device Lot NumberR58536053
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/22/2017 Patient Sequence Number: 1
Treatment
ATROPINE SULFATE 1 PERCENT QID PRN; FLUCONAZOLE 200 MG PO QD; IBUPROFEN 800 MG TID; OTC MEDS: IBUPROFEN 800 MG TID; RX MEDS: NATACYN 5 PERCENT OPHTHALMIC (1 GTT QH); THERA TEARS PRESERVATIVE FREE PRN; TYLENOL 1000 MG BID; TYLENOL 1000MG BID; VALACYCOLVIR 500MG P.O. BID; VIGAMOX 0.5 PERCENT 1 GTT TID
-
-