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

Model Number CI-28

Device Problems Insufficient Information (3190); Device Handling Problem (3265)

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

Event Date 10/02/2019

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation.Investigation of this event is in progress.Upon completion of the investigation, a follow up report will be submitted.

Event Description

It was reported that an intraoperative exchange on the left eye took place due to the trailing haptic of the initial intraocular lens (iol) being cut in half by the insertion device during iol implantation.The incision was enlarged almost as wide as the optic in order to remove the iol prior to lens exchange.A suture was placed after the intraoperative lens exchange.In the surgeon's opinion, the likely cause of the event was the insertion device cut off the trailing haptic of the optic.The patient has recovered.

Manufacturer Narrative

Additional information: additional visual inspection was completed for this event.The investigation team inspected 3 retain inserters from lot h956901l under 10x-20x magnification.All retain samples showed no presence of particulate or flash in the lens path that could have caused any damage to the lens in the manner described in the event.Based on the results of the visual inspection performed on the lens, the three retain inserters from lot h953502, and the information provided by the account rep, no issues were observed that can confirm the description of the reported event.The results showed that the inserters were assembled for intended use and shipped with no damages and packaged as intended to keep good condition for use.The additional information does not change the investigation findings submitted in the previous report.

Manufacturer Narrative

Additional information: the product was not returned for evaluation.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.There have been no other complaints for this lot to date.The duovisc viscoelastic used is not validated for use with b&l products, therefore 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 north goodman street; rochester NY 14609
• MDR Report Key: 9280010
• MDR Text Key: 174296789
• Report Number: 0001313525-2019-00171
• 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,Followup
• Report Date: 01/01/2005,10/07/2019

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 Expiration Date: 05/24/2020
• Device Model Number: CI-28
• Device Lot Number: H953502
• Was Device Available for Evaluation?: No
• 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: 10/09/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 11/08/2019; 12/03/2019
• Supplement Dates FDA Received: 11/21/2019; 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUOVISC VISCOELASTIC, CRYSTALENS AO1UV IOL.
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR