MAUDE Adverse Event Report: BAUSCH + LOMB, INC. PHACO ACCESSORY PACK; UNIT, PHACOFRAGMENTATION

Model Number	DP5501
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user veterinary facility reports that during the procedure (when sculpting a bowl and nearing the posterior cortex), the phaco sleeves are splitting open near the point where the cylindrical part meets the screw-on base.Although this site is outside of the eye, when it splits open a fountain erupts and the anterior chamber becomes very shallow, posterior capsule emerges between two lens fragments and is caught by phaco tip, and then fluid surges (machine senses the loss of pressure) and the lens fragments are pushed through the posterior capsule into the vitreous.
Additional Manufacturer Narrative
The manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is underway.
Additional Manufacturer Narrative
Correction, d1.Phaco accessory pack; h5.Yes.Twelve light blue irrigation sleeves were returned.Nine were returned double pouched inside unknown sealed sterilization pouches.Eight have the date (b)(6) 2024 handwritten on the pouch and one does not have a date.There are also three light blue irrigation sleeves at the bottom of the box loose.The part number and lot number cannot be verified or determined.The expiration date cannot be verified or determined.All nine pouches and the three loose irrigation sleeves were opened by the complaint evaluation center technician for microscopic examination.Visual inspection found three sleeves have areas inside the sleeve shaft that appear worn with abrasion marks.The needles used were not returned and the needle types are unknown.Microscopic examination found one sample has a visible tear running lengthwise up the shaft near the hub.Two samples with the tip/aspiration port are oval/flattened rather than round.The three sleeves from the bottom of the box are dirty with particulates and dried solutions all over.They look used.One sleeve shaft is torn off and missing.After cleaning the torn sleeve, it has what looks like scratches, and abrasions running lengthwise.Two sleeves have irrigation holes that appear off center and the tips are oval/flattened.In eye conditions cannot be duplicated.Due to evidence of use, the cause of the damaged sleeves cannot be determined.These samples will be sent to the vendor for evaluation.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action is required.See related 0001920664-2024-00106.
Additional Manufacturer Narrative
The vendor evaluated the samples and stated that out of the 12 samples that were sent in for evaluation, 5/12 exhibited voids in the threads and 2/12 had tears on the shaft.Parts are 100% manually inspected during routine production.A qc sampling is performed at start up, mid-shift and a final at the end of production.The vendor will continue to monitor for this issue via their ncmr process and monthly/quarterly complaint trending.The investigation is complete.See related 0001920664-2024-00106.

• Brand Name: PHACO ACCESSORY PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC.; 4100 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 20064365
• Report Number: 0001920664-2024-00105
• Device Sequence Number: 20765514
• Product Code: HQC
• UDI-Device Identifier: 10757770055828
• UDI-Public: (01)10757770055828(17)280806(10)X4887
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2024

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
• Device Model Number: DP5501
• Device Lot Number: X4887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 09/16/2024; 12/23/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/14/2024; 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• 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: STELLARIS SYSTEM AND ACCESSORIES
• Patient Sex: Unknown