MAUDE Adverse Event Report: BAUSCH + LOMB CRYSTALSERT INSERTER; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number CI-28

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

Patient Problem Pain (1994)

Event Date 12/18/2018

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that the lens was tilted asymmetrically in the left eye at time of implantation.Despite rotating and re-positioning, the lens remained tilted.Patient discomfort and pain made the removal and replacement of the lens unsafe during the initial procedure.The lens was then explanted approximately one month post-op and replaced with a different model lens.The patient's current prognosis is very good post exchange.In the physician's opinion the cause of the event is unknown.

Manufacturer Narrative

Additional information: the device was not returned for evaluation and the lot number was not provided; therefore, a device history review (dhr) and product evaluation could not be conducted.Based on the information available, the root cause of the reported event could not be conclusively determined.

• Brand Name: CRYSTALSERT INSERTER
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 8318945
• MDR Text Key: 135522440
• Report Number: 0001313525-2019-00029
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• PMA/PMN Number: K082944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CI-28
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CRYSTALENS ACCOMMODATING INTRAOCULAR LENS
• Patient Outcome(s): Other
• Patient Age: 56 YR