MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC LAMINAR FLOW PHACO TIP FLRD TIP 30D 20G SL REUSE; PHACO ACCESSORY

Model Number	OPOF3020R
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: phacofragmentation unit serial no.(b)(4), phaco handpiece, tubing pack.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
During a cataract procedure, the tip became occluded/clogged using a reusable opof3020r- laminar flow phaco tip.A brief description from the surgery center indicated there was a clogged tip during the procedure, hence the procedure was aborted and not completed.The surgery center reported 501 error has been occurring frequently and it is unknown if the 501-error occurred during the procedure.Although, there was an attempt to restart the phacoemulsification unit, replace the phaco handpiece, and replace the tubing pack, the occlusion was still present.The patient was sent home.No additional information will be provided by the surgery center.No patient injury was reported.This report is for the phaco tip.A separate report will be submitted for the phacofragmentation unit.
Additional Manufacturer Narrative
Historical record review was performed.Based on the historical record reviews, all devices met material, assembly and performance specifications at the time of product released.The supplier conducts a 100% visual inspection of the final device and components as part of the acceptance process.Therefore, the possibility of this failure happened during manufacturing is low.Johnson and johnson surgical will continue monitor this type of complaints.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 nr-0148919 and capa-010215.

• Brand Name: LAMINAR FLOW PHACO TIP FLRD TIP 30D 20G SL REUSE
• Common Device Name: PHACO ACCESSORY
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC; santa ana CA
• MDR Report Key: 8086762
• Report Number: 3006695864-2018-02144
• Device Sequence Number: 1620620
• Product Code: HQC
• UDI-Device Identifier: 05050474573529
• UDI-Public: (01)05050474573529(17)171130(10)D34881
• Combination Product (Y/N): Y
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OPOF3020R
• Device Catalogue Number: OPOF3020R
• Device Lot Number: D34881
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 01/02/2019; 10/25/2020
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 01/23/2019; 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005