MAUDE Adverse Event Report: BAUSCH + LOMB BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number BLIS-X1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blurred Vision (2137); No Code Available (3191)

Event Date 01/30/2020

Event Type  Injury  

Manufacturer Narrative

The reporter has indicated the injector is not available for return.The investigation is in progress.A follow up report will be submitted as additional information is received.

Event Description

It was reported that during surgery, the surgeon noticed that the intraocular lens (iol) implanted into the left (os) eye, appeared to have a scratch on the optic.The lens was removed and replaced intraoperatively with an iol of the same model and diopter.The second iol implanted successfully.There was no damage to the capsular bag, no loss of vitreous.There was no vitrectomy and the plan of surgery did not change.However, the incision was enlarged in order to remove the lens and sutures were required.In the physician's opinion, the most likely cause of the iol damage was forceps/handling.The patient's current prognosis was blurry vision at 24hrs.At 48 hrs, vision was improving.The doctor has continued to monitor and the patient is doing very well and the vision has improved immensely.

Manufacturer Narrative

The product was not returned for evaluation as it was discarded by the user facility.Per the reporter, the event is believed to be related to product handling.A device history record (dhr) review could not be performed as no lot number had been provided.The trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Damage to the intraocular lens (iol) may be rooted in the loading procedure.An insufficient amount of viscoelastic could be the cause of the issue.Additionally, improper manipulation using hard tip plungers is a common root cause for scratches on the optic.No corrective action is necessary at this time.

Event Description

Further clarification was received from the account that forceps were not used but the event is believed to be related to product handling.

• Brand Name: BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 9757805
• MDR Text Key: 183917240
• Report Number: 0001313525-2020-00044
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• PMA/PMN Number: K131958
• 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: 01/01/2005,02/03/2020

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: BLIS-X1
• Device Catalogue Number: BLIS-X1
• Device Lot Number: UNKNOWN
• 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: 02/03/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 03/23/2020
• Supplement Dates FDA Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OCUCOAT VISCOELASTIC, ENVISTA INTRAOCULAR LENS
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR