MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. LAMINAR FLOW PHACO TIP; PHACO ACCESSORY

Model Number	OPOR0020L
Medical Device Problem Codes	Failure to Prime (1492); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown as it was not provided.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
During a cataract procedure, the phaco tip was clogged.A description from the surgery center indicated during the phaco procedure, a 501-priming error displayed.The surgery center replaced the tubing pack; however, the issue was not resolved.It was noted the inside of a new tip was clogged.The procedure was completed successfully using a backup.No patient injury is reported.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 10/02/2019.Device returned to manufacturer: yes.Device evaluation: a visual inspection of the phaco tip shows that the distal tip was occluded with a translucent particle.The particle was removed and examined under magnification.The particle material is consistent with the yellow phaco sleeves used in conjunction with the tip.Due to the sharp cutting needle of the phaco tip, pieces of the silicone protective cover, phaco sleeve, or test chamber may be cut and become lodged in the phaco tip during application/preparation for procedure.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.A complaint history review was performed, and no other related complaint was reported against opor0020l lot# 4038087.Clear silicone is possibly the material from protective tubing that came with the device as to protect the phaco tip during transportation.Lake regional medical has implemented the 100% inspection after protective silicone attached to the phaco tip prior to product released.Therefore, the possibility of this failure happened during manufacturing is low.Johnson and johnson surgical will continue monitor this type of complaints per global complaint trending.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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
• Common Device Name: PHACO ACCESSORY
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8980065
• Report Number: 3006695864-2019-00730
• Device Sequence Number: 14283887
• Product Code: HQC
• UDI-Device Identifier: 05050474521124
• UDI-Public: (01)05050474521124(17)201130(10)4038087
• 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): 11/10/2020
• 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 Expiration Date: 11/30/2020
• Device Model Number: OPOR0020L
• Device Catalogue Number: OPOR0020L
• Device Lot Number: 4038087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 10/21/2019; 10/25/2020
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 11/12/2019; 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TUBING PACK; TUBING PACK
• Date Report Sent to FDA: 01/01/2005