MAUDE Adverse Event Report: BAUSCH + LOMB FINE TIP ECKARDT ILM FORCEPS; ECKARDT FINE TIP FORCEPS 23GA

Model Number 39.10.23

Device Problem Material Fragmentation (1261)

Patient Problem Loss of Vision (2139)

Event Date 09/13/2016

Event Type  Injury  

Manufacturer Narrative

Bausch + lomb received notification of this event from the patient's attorney via a civil action complaint.The event was not reported by the medical professional during the time the patient was under treatment in 2016 and 2017.At this time we have no further information regarding the device or the cause of the event.

Event Description

On (b)(6) 2016 the patient underwent a left eye pars plana vitrectomy and membrane peel.The doctor completed the membrane peel when one of the tips broke off and came to rest in the patients superior macula.The doctor enlarged the sclerotomy site in an attempt to remove the tip from the patients eye, but was not successful.The patient suffered from a suprachoroidal hemorrhage and as a result underwent a left eye choroidal hemorrhage drainage.The patient suffered blurry vision and hemorrhage drainage was repeated two more times.On (b)(6) 2017 the doctor performed surgery and successfully removed the tip from the patients eye.The patient had blurry vision due to a corneal abrasion.On (b)(6) 2017 the patient was diagnosed with corneal scarring, optic nerve damage, and retina damage as a result of the choroidal hemorrhage.On (b)(6) 2017 the patient suffered a left globe rupture and underwent a left eye enucleation.

Manufacturer Narrative

Synergetics has not manufactured this product in over 7 years.There are two repair records available from this facility for this part number (serial #(b)(4)).The last repair was performed in (b)(6) 2014.There is insufficient information available to pursue corrective action.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No additional investigation can be performed due to no lot number or product sample.

• Brand Name: FINE TIP ECKARDT ILM FORCEPS
• Type of Device: ECKARDT FINE TIP FORCEPS 23GA
• Manufacturer (Section D): BAUSCH + LOMB; 1400 goodman rd; rochester NY 14609
• MDR Report Key: 7881845
• MDR Text Key: 120440770
• Report Number: 0001932402-2018-00015
• Device Sequence Number: 1
• Product Code: HNR
• Combination Product (y/n): Y
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

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 Operator: Health Professional
• Device Model Number: 39.10.23
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention