MAUDE Adverse Event Report: BAUSCH + LOMB ADAPTIVE FLUIDICS STANDARD PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL5115-2
Medical Device Problem Codes	Increase in Suction (1604); Inaccurate Delivery (2339); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Corneal Scar (1793); Visual Impairment (2138); Eye Burn (2523)
Date of Event	05/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility in france reported that during cataract surgery there was no irrigation which led to overheating and a corneal burn.Beforehand a test was performed by an intern surgeon, who initiated the continuous irrigation outside the eye which was functional.After approximately 30 seconds of the sculpting phase (4-5 movements to carve out the main groove), the chamber collapsed, and the surgeon noticed coagulation of the crystalline proteins (white eye).Immediately, the phaco was removed and it was noticed that no irrigation was present, the tip was warm and that there was an incision burn.The surgeon continued the surgery by changing the cassette, all the tubing and the phaco tip, while abundantly irrigating the incision with cold saline solution.The incision was very difficult to close, requiring two stitches of monofilament without the possibility of a complete water tightness.The surgeon also injected a viscous solution into the incision to try to seal it better.The post-surgery anti-inflammatory medication was increased to 6 doses of tobradex (tobramycine and dexamethason) eye drops, per day and a contact lens dressing was applied.The surgery time was increased by 10-15 minutes.On day two post-op, the patient was airtight, however the visual acuity remained low (around 1/10 compared with 6/10 preop), due to significant corneal astigmatism (partly related to the sutures and partly to the corneal scar, which was irreducible according to the surgeon).Moreover, the patient presented descemet folds, as a result of the heating, which also contributed to the drop in visual acuity.The patient also suffers from bilateral exudative amd treated with antivegf, which has led to a loss of function in the contralateral eye (right eye), leaving her monophthalmic in the left eye where the incident occurred.
Additional Manufacturer Narrative
The product has not been received and the lot number is unknown.The investigation is ongoing.
Event or Problem Description
The patient last visual acuity was 1.6/10 with persistent irregular corneal astigmatism (-5d cylinder).
Additional Manufacturer Narrative
The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• Brand Name: ADAPTIVE FLUIDICS STANDARD PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; saint louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 17408426
• Report Number: 0001920664-2023-70073
• Device Sequence Number: 12602042
• Product Code: HQC
• UDI-Device Identifier: 00757770058853
• UDI-Public: (01)00757770058853
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: BL5115-2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALANCED SALT SOLUTION (BSS-10PK)
• Patient Sex: Female