MAUDE Adverse Event Report: BAUSCH + LOMB CRYSTALENS ACCOMMODATING IOL; LENS, INTRAOCULAR, ACCOMMODATIVE

Model Number AO1UV

Device Problems Difficult to Advance (2920); Mechanical Jam (2983)

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

Event Date 04/10/2018

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 back of the lens got stuck in the ci-28 injector during the procedure.The incision was enlarged but no sutures were required.Additional information has been requested, but no additional information has been received.

Manufacturer Narrative

The lens was not returned for evaluation; therefore, a product evaluation could not be performed.The device history record (dhr) was reviewed and there were no discrepancies or deviations found.Based on available information, a root cause for the reported event could not be conclusively determined; however, it is possible that user related factors (such as loading or handling technique) and/or procedural factors (such as lens and injector interaction) may have caused or contributed to the event.

• Brand Name: CRYSTALENS ACCOMMODATING IOL
• Type of Device: LENS, INTRAOCULAR, ACCOMMODATIVE
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: tes proud ; 1400 north goodman street; rochester, NY 14609 ; 5853388549
• MDR Report Key: 7496846
• MDR Text Key: 107685394
• Report Number: 0001313525-2018-00099
• Device Sequence Number: 1
• Product Code: NAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2020
• Device Model Number: AO1UV
• Device Catalogue Number: AO1UV-2150
• Device Lot Number: 7568211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2015
• 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
• Patient Outcome(s): Other