MAUDE Adverse Event Report: BAUSCH + LOMB HANDHELD SURGICAL INSTRUMENT; KOCH CHOPPER

Model Number E0713

Device Problem Particulates (1451)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

Based on all information, no causal factors can be determined and no conclusion can be drawn.

Event Description

Patient has metallic particles in iris.The doctor believes it is coming from the e0713 koch chopper used on the patients cataract surgery 6 months ago but is really unsure.Additional information has been requested on the impact to the patient.

Manufacturer Narrative

Additional information received on patient impact.The piece is really small, probably smaller than a piece of salt or ground pepper.It was sitting on the mid peripheral iris and seen on regular slit lamp biomicroscopy.The patient is asymptomatic.It was noted on exam when we were examining him for vitreous hemorrhage.It does not appear to be causing any intraocular inflammation.And as far as the doctor can tell, no signs of retinal toxicity.

Manufacturer Narrative

Changed to adverse event.Adverse event due to possible intervention may have been required; however intervention was not performed.Previously reported by the doctor: the piece is really small, probably smaller than a piece of salt or ground pepper.It was sitting on the mid peripheral iris and seen on regular slit lamp biomicroscopy.The patient is asymptomatic.It was noted on exam when we were examining him for vitreous hemorrhage.It does not appear to be causing any intraocular inflammation.And as far as i can tell, no signs of retinal toxicity.

• Brand Name: HANDHELD SURGICAL INSTRUMENT
• Type of Device: KOCH CHOPPER
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 499 sovereign court; manchester MO 63011
• Manufacturer Contact: juli moore ; 3365 tree court industrial blv; st. louis, MO 63122 ; 636226-322
• MDR Report Key: 6079026
• MDR Text Key: 59229604
• Report Number: 0001920664-2016-00400
• Device Sequence Number: 1
• Product Code: HNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: E0713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other