MAUDE Adverse Event Report: BAUSCH AND LOMB INC. TRULIGN TORIC IOL; INTRAOCULAR LENS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Blurred Vision (2137); Visual Impairment (2138); Halo (2227)

Event Date 12/08/2014

Event Type  Injury  

Event Description

Had a cataract operation and with trulign iol installed.Vision did not turn out to be as was represented when i selected and paid a premium for the lens, which was supposed to enable me to see clearly at a distance at intermediate distance and perhaps also at reading distance, that is without the need of glasses.My vision is not clear at any distance except about 2 feet.Plus have several types of visual aberrations: flickering, halos, rays, starbursts and haze around bright objects in dimly lit conditions.Had 2 subsequent surgeries to try to correct problems.Had supportive ring installed which accomplished nothing then a piggyback lens, which did alleviate the flickering, but made the night vision problems worse.In addition had yag procedure to try to alleviate haziness with marginal benefit.In short, the lens never worked as represented and the vision in the eye that was operated on is worse than my other eye with worsening cataract, which i have been reluctant to have surgery on because of what happened to the first eye.

• Brand Name: TRULIGN TORIC IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH AND LOMB INC.
• MDR Report Key: 7637908
• MDR Text Key: 112493401
• Report Number: MW5078061
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/23/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 57