MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC PHACOFIT TITANIUM 0.3MM 45O TIP; PHACO ACCESSORIES

Model Number	OM0551013
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown as it was not provided.Manufacturer date is not provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
During a cataract extraction procedure, the surgery center reported an irrigation/aspiration(i/a) tip is causing capsular tears.A brief description from the surgeon indicated the i/a tip had slightly picked up the posterior capsule and made a slight tear.The surgeon indicated the tip was jagged and not straight anymore.The procedure was completed successfully.
Additional Manufacturer Narrative
Per manufacturing records review report, no related non-conformity or deviations were issued during manufacturing the pi lot# 122214.All devices met material, assembly and performance specifications at the time of product released.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device available for evaluation? yes device returned to manufacturer on 10/08/2018.Device returned to manufacturer? yes device evaluation: unit returned with numerous scratches and dents on the distal working end around the aspiration port, on the top of the rounded end, on the front, back and sides of the bend, dents and scratches around both ports of the irrigation cannula.There is considerable deformation of the aspiration cannula: the aspiration cannula is flattened slightly by a sizable dent on the backside of the bend.The bend angle of this cannula, as produced, should be around 45 degree but is now at about 30 degree.The metal irrigation cannula has a few dents around the edge of one irrigation port.Assembly and packaging level routers for lot 122214 were pulled.No anomalies were identified.This unit would not have been shipped in this condition and failed final inspection per standard operating procedure.The condition of this tip suggests it has made repeated contact with other metallic objects, either during surgery or reprocessing.The scratches and gouges could not be due to direct contact with other ophthalmic instruments in surgery or due to rough handling during cleaning and sterilization.The dents and decreased bend angle could be due to accidental dropping or bumping of the unit during handling.The dfu for i/a tips states that the product should be inspected for damage post-cleaning and post-use.Therefor the unit should not have been used.This complaint will be filed as ''customer use issue'' and ''customer maintenance issue'' since the unit was used after being damaged.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-010215.

• Brand Name: PHACOFIT TITANIUM 0.3MM 45O TIP
• Common Device Name: PHACO ACCESSORIES
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC; santa ana CA
• MDR Report Key: 7799113
• Report Number: 3006695864-2018-01710
• Device Sequence Number: 2076139
• Product Code: HQC
• UDI-Device Identifier: 05050474500426
• UDI-Public: (01)05050474500426(17)991231(10)122214
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/02/2020
• Report Date (Section F): 01/01/2005

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 Model Number: OM0551013
• Device Catalogue Number: OM0551013
• Device Lot Number: 122214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 08/27/2018; 10/08/2018; 10/25/2020
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 09/21/2018; 10/23/2018; 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005