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

Model Number CI-28

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/06/2017

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 haptics of a toric lens sheared off during implantation, resulting in the lens having to be removed from the eye.A second toric lens was then attempted for implantation, but the haptics once again sheared off.This lens also had to be removed from the eye.No incision enlargement or sutures were necessary during the surgery, but the patient was left aphakic at the end of the procedure.The patient then returned four days later and had a different model lens successfully implanted with no issues.This mdr is for inserter 2 of 2.

Manufacturer Narrative

The device was not returned for evaluation.A lot number was not provided, so a device history record (dhr) could not be performed for this device.Based on the available information, the exact root cause could not be conclusively determined.However, it is likely that user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) may have caused or contributed to the event.

• Brand Name: CRYSTALSERT INSERTER
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: faranak gomarooni ; 50 technology drive west; irvine, CA 92618 ; 9493985708
• MDR Report Key: 6602244
• MDR Text Key: 76303480
• Report Number: 0001313525-2017-02572
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: CI-28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TRULIGN TORIC IOL
• Patient Outcome(s): Other