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

Model Number CI-28

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

According to the reporting facility, the product is not available for evaluation.As the lot number is unknown, a review of the device history record could not be performed.A review of the nonconformance database did not identify any anomalies for this product that could have contributed to the reported event.The trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.The most probable root cause is operational context.User related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to the event.No corrective action is necessary at this time.

Event Description

During insertion of the intraocular lens (iol) into the patient¿s right eye, the back haptics tore off the lens after becoming stuck to the injector.The lens was removed intraoperatively, requiring enlargement of the incision from 2.75mm to 3.5mm.No sutures were required.A replacement lens of the same model and diopter was successfully placed.The surgery was phaco only, and no other procedural complications occurred.The patient is not believed to have experienced a decrease in vision.In the surgeon's opinion, the cause of the damage is that the lens was stuck in the delivery device.The patient's outcome is good.

• Brand Name: CRYSTALSERT INSERTER
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman; rochester NY 14609
• Manufacturer Contact: stephanie anastasiou ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246659
• MDR Report Key: 10551745
• MDR Text Key: 207562850
• Report Number: 0001313525-2020-00130
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K082944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/01/2005,08/26/2020

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 Catalogue Number: CI-28
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/17/2020
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CRYSTALENS IOL, PROVISC VISCOELASTIC
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR