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

Model Number CI-28

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Vitreous Loss (2142); Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

The delivery device has not been returned for evaluation.The investigation is on-going.A follow up report will be submitted when additional information becomes available.

Event Description

It was reported that upon insertion of the intraocular lens (iol) into the right (od) eye, the haptic tore away from the lens body.The iol damage was noticed intraoperatively and the iol was removed with lens cutters.The capsular bag was damaged and the surgery was aborted due to hemorrhage and a loss of vitreous.A vitrectomy was performed.The incision was not enlarged, but a suture of 10.0 nylon was used.The plan of surgery changed and the patient was left aphakic with no secondary iol implanted until visual status has stabilized.Patient has been referred to a retina specialist with a plan for a 2° anterior chamber (ac) lens later.The patient's prognosis is good.In the physician's opinion, the most likely cause of the iol damage was a defective lens.

Manufacturer Narrative

The delivery device was returned for evaluation in the associated intraocular lens (iol) box with the tip bent.The original packaging was not returned.The lot number was not able to be confirmed from the returned device.There was very little dried solution visible in the loading deck or in the tip.Functional testing could not be performed due to the damage.The device history record (dhr) was reviewed and there were no discrepancies or deviations found that related to the reported issue.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

It was reported that the patient has seen a retina specialist but has not followed up with the implanting surgeon.Though requested, no additional patient outcome information has been received.

• 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: 9759334
• MDR Text Key: 183917594
• Report Number: 0001313525-2020-00047
• 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: 01/01/2005,02/12/2020

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 Expiration Date: 04/09/2020
• Device Model Number: CI-28
• Device Catalogue Number: CI-28
• Device Lot Number: H963802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• 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: 02/12/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMVISC VISCOELASTIC, CRYSTALENS AO1UV, BAXTER BSS
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR