MAUDE Adverse Event Report: BAUSCH & LOMB INCORPORATED CRYSTALENS; LENS, INTRAOCULAR, ACCOMMODATIVE

Model Number AT50AO-1800

Device Problems Defective Device (2588); Material Twisted/Bent (2981)

Patient Problems Visual Disturbances (2140); Eye Pain (4467)

Event Date 01/01/2020

Event Type  Injury  

Event Description

The crystalens by bausch & lomb had a twist called "z syndrome".Product crystal lense still on market.I have had 5 operations because of faulty crystalens (bausch & lomb).Just read others comments and protect the public.Do your job.Difficulty seeing, eye hurt all the time.Lens removed due to suspected tilt/z-syndrome.

• Brand Name: CRYSTALENS
• Type of Device: LENS, INTRAOCULAR, ACCOMMODATIVE
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED
• MDR Report Key: 11640824
• MDR Text Key: 244867988
• Report Number: MW5100668
• Device Sequence Number: 1
• Product Code: NAA
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: AT50AO-1800
• Device Catalogue Number: AT50AO-1800
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other