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 Edema (1820); Visual Impairment (2138); No Code Available (3191)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been received for evaluation.The investigation is ongoing.

Event Description

It was reported that after implanting an intraocular lens (iol) into the left (os) eye during a routine cataract phacoemulsification surgery, a crack was noticed on the corner of the optic and part of the trailing haptic had broken off.The lens was successfully removed and replaced with a back up lens of the same model and diopter intraoperatively, however, the incision was enlarged from 2.2mm to ~3.0 - 3.5mm to remove the iol and 3 sutures were required.The procedure was prolonged by 20 minutes, but no additional anesthesia was administered.The patient noticed a decrease in their vision due to edema on post-op day 1 due to iol explant.

Manufacturer Narrative

The device was not returned for evaluation.As the lot number is unknown, the associated device history record was unable to be reviewed.A review of nonconformities found no similar events that would 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 for this event is user error, most likely a loading error.The loading of the iol is essential for the performance of the injector and its cartridge.The loading instructions must be carefully followed.Issues during the loading process may have led to lens damage.No corrective action is necessary at this time.

• 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: 10733686
• MDR Text Key: 213020893
• Report Number: 0001313525-2020-00161
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MX60P IOL, UNKNOWN VISCOELASTIC; MX60P IOL, UNKNOWN VISCOELASTIC
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR