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

Model Number CI-28

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Visual Impairment (2138)

Event Date 10/14/2021

Event Type  Injury  

Manufacturer Narrative

Although requested, the device was not returned for evaluation.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be conclusively determined; however patient related factors may have caused or contributed to this event.

Event Description

It was reported that an intraocular lens (iol) was removed six weeks post implant due to the patient noticing a decrease in their vision.The lens was replaced with different model and diopter lens.In the surgeon¿s opinion, the likely cause of the event was due to capsular contraction.Patient outcome is reportedly good.

• 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
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759
• MDR Report Key: 12805569
• MDR Text Key: 281129728
• Report Number: 0001313525-2021-00141
• 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: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/15/2021

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
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CRYSTALENS ACCOMMODATING IOL
• Patient Outcome(s): Required Intervention