MAUDE Adverse Event Report: BAUSCH + LOMB 23GA HORIZONTAL SCISSORS, MEDIUM CURVE, FINE TIP; HANDHELD SURGICAL INSTRUMENT

Model Number D23.76.23

Device Problems Particulates (1451); Insufficient Information (3190)

Patient Problem Vitrectomy (2643)

Event Date 07/17/2019

Event Type  Injury  

Manufacturer Narrative

The sterilization and lot history records were reviewed and found to be acceptable.Further investigation underway.

Event Description

The user facility reported the appearance of metallic particles during surgery at the level of iris surface and in the anterior chamber.The particles could not be removed from the patients iris.The anterior chamber was repaired, and an anterior vitrectomy was performed using scissors to cut vitreous strap.Devices were changed to perform the surgery.Patient control at day 1 and day 7: patient¿s eye was not inflamed.Particles are noticeable during slit-lamp examination.Patient visual acuity was 10/10 without functional complaint.Fundi examination was normal.

Manufacturer Narrative

The evaluation was completed.The instrument was examined under 45x magnification.There was no metallic debris seen on the part.The scissors and most particularly the space behind the scissor in between the arms was coated with dried surgical debris.There were no areas identified on the part that looked like they may have been damaged or had metal particulate present.The disposable tip was examined under magnification typically used during the manufacture of the device.There were no worn areas, slivers or burrs seen on the instrument.There was some evidence of corrosion seen on the instrument on the back end of the d-tip.The report was not confirmed as there was no metal debris or indications that any metal debris was generated from the disposable scissor seen in the evaluation of the unit returned.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.

• Brand Name: 23GA HORIZONTAL SCISSORS, MEDIUM CURVE, FINE TIP
• Type of Device: HANDHELD SURGICAL INSTRUMENT
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 9089027
• MDR Text Key: 163576116
• Report Number: 0001932402-2019-00004
• Device Sequence Number: 1
• Product Code: HNF
• Combination Product (y/n): Y
• PMA/PMN Number: EXEMPT
• 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: 01/01/2005,08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2021
• Device Model Number: D23.76.23
• Device Lot Number: M0015209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALCON ANT VITRECTOMY PROBE. CLEARCUT SLIT KNIFE.
• Patient Outcome(s): Required Intervention