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

Model Number CI-28

Device Problems Mechanical Problem (1384); Device Handling Problem (3265)

Patient Problems Eye Injury (1845); No Code Available (3191)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

One delivery device was returned in the lens box with the tip bent.The original packaging was not returned.The lot number cannot be determined.Visual inspection found one plate of the intraocular lens was torn off and is stuck in the tip of the returned delivery device.Functional testing of the delivery device cannot be performed due to the damage.Further investigation is in progress.A follow up report will be submitted upon completion of the investigation.

Event Description

It was reported that during insertion of the intraocular lens (iol), the trailing haptic was stuck in the inserter cartridge and snapped off.Half of the haptic was inside the patient¿s eye.The lens and damaged haptic were removed intraoperatively.No incision enlargement was necessary, but 10.0 nylon sutures were placed, which was not part of standard protocol.The capsular bag was not damaged and there was no loss of vitreous.A second iol of the same model and diopter was successfully implanted.The patient is now feeling well as of the follow-up appointment.In the physician's opinion, the most likely cause of the iol damage was that the lens was stuck in the delivery device.

Manufacturer Narrative

Additional information: the product evaluation confirmed the failure mode.The lot history, 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.

• Brand Name: CRYSTALSERT INSERTER
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman; rochester NY 14609
• MDR Report Key: 9286522
• MDR Text Key: 179117458
• Report Number: 0001313525-2019-00177
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/08/2019

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• 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: 10/08/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 11/07/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CRYSTALENS AO1UV-2250, HEALON, ENDOCOAT
• Patient Outcome(s): Required Intervention