MAUDE Adverse Event Report: BAUSCH + LOMB, INC. 20GA ONE-STEP¿ SUTURELESS CANNULA; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	58.20-6
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a one-step sutureless cannula failed during surgery.When the surgeon attempted to remove the trocar at the end of the procedure, the top of the trocar broke off leaving the cannula in the eye.The surgeon had to go back into the eye and retrieve the cannula part of the trocar that fell down onto the retina.A 20ga incision was made to enlarge the incision using a v-lance blade.After several attempts of trying to retrieve the cannula with different types of forceps, the surgeon decided to use a chandelier light fiber so that two forceps could be used to grasp the cannula.The cannula was then removed from the back of the eye.Incision was enlarged, but no sutures were required.
Additional Manufacturer Narrative
The product was returned but not evaluated yet.This investigation is ongoing.
Additional Manufacturer Narrative
The cannula was returned in an alcon product tray inside a synergetics product pouch for a 58.20-6 one-step sutereless cannula.This cannula was manufactured by an external supplier.The polyimide tube that gets bonded to the abs hub is in two pieces, one loose in the tray, one still bonded to the hub.The break in the tubing is irregular and jagged, with splits or cracks evident.Part of the tubing still attached to hub appears to be rolled inward suggesting the tube bent or folded prior to breaking.The device history review did not reveal any negative quality patterns and there were no associated non-conformances.The vendor reported inspection for through hole diameter (to ensure no resistance with 20ga instruments inserted) and for polyimide/cannula bond strength, this defect would have been detected prior to packaging.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 required.
Event or Problem Description
The incision was enlarged and 8-0 vicryl was used to close the sclerotomy.
Additional Manufacturer Narrative
Correction: b1, b2, b5, h1.¿ type of reportable event¿, h10.6 ¿health effect impact code 1¿.

• Brand Name: 20GA ONE-STEP¿ SUTURELESS CANNULA
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): BAUSCH + LOMB, INC.; 4100 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): SYNERGETICS, INC.; 3845 corporate centre dr.; o'fallon MO 63368
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 17969750
• Report Number: 0001932402-2023-70006
• Device Sequence Number: 6790456
• Product Code: MDM
• UDI-Device Identifier: 20841305108176
• UDI-Public: (01)20841305108176(17)251117(10)M0045868
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2025
• Device Model Number: 58.20-6
• Device Lot Number: M0045868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 09/20/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 11/17/2023; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2022
• 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: 23GA ALCON VITRECTOMY PACK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown