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

Model Number	BLIS-R1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypopyon (1913); Loss of Vision (2139); Toxic Anterior Segment Syndrome (TASS) (4469); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the one-day post-operative visit after implantation of an intraocular lens (iol) into the left eye, the surgeon noted the patient presented with 1+ edema, 4+ fibrin, and trace sliver of hypopyon.This reaction was diagnosed as toxic anterior segment syndrome (tass).In the surgeon's opinion, the most likely cause of event is possibly from the visco and lido/phen.Patient outcome is good.The following medications were prescribed for use at home postoperatively: neomycin & polymyxin & dexamethasone dose: 1 small ribbon frequency: once pred-moxi-brom 1%,.5%, 0.075% dose: 1gtt frequency: tid 2 weeks, bid 1 week, qd 1 week durezol dose: 1gtt frequency: qhourly duration: till directed otherwise moxifloxacin dose: 1gtt frequency: qhourly duration: till directed otherwise.
Additional Manufacturer Narrative
The serial number of the handpiece used in the event was not recorded by the account.As a serial number for the device was not provided, the associated device history record was not reviewed.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be conclusively determined.

• Brand Name: BAUSCH + LOMB INJECTOR SYSTEM HANDPIECE
• Common Device Name: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 499 sovereign court; manchester MO 63011
• Manufacturer Contact: shayan habibi ; 21 n park pl blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 19940162
• Report Number: 0001313525-2024-00133
• Device Sequence Number: 4952965
• Product Code: MSS
• UDI-Device Identifier: 00757770520176
• UDI-Public: (01)00757770520176
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K131958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/24/2024

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: BLIS-R1
• 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: 07/09/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENVISTA IOL, AMVISC PLUS, BLIS-X1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male