MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC PROFICIENT PHACO NEEDLES; PHACO ACCESSORY

Model Number	OPOR3021G
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Manufacturer date is unknown.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The surgery center observed under the microscope, a plastic part was seen in the opening of a newly single use phaco tip resulting in obstruction of flow.A description from the account reported the phacofragmentation unit got stuck after tightening a newly open single use phaco tip.The tip was replaced and the procedure was completed.No patient injury reported.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 09/12/2018.Device returned to manufacturer ¿ yes.Device evaluation: one phaco tip received without protective silicone tubing or irrigation sleeve.Under microscope a silicone-like particle was observed.The reported complaint and the material could not be confirmed as the protective silicone tubing and sleeve were not provided for evaluation.The supplier conducts a 100% visual inspection of the final device and components as part of the acceptance process.Based on visual inspection of the return and the supplier's inspection process, there is no root cause identified.Probable cause may be associated with the silicone tubing cover being used during the attachment of the tip to the handpiece.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 nr-0148919 and capa-010215.

• Brand Name: PROFICIENT PHACO NEEDLES
• Common Device Name: PHACO ACCESSORY
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC; santa ana CA
• MDR Report Key: 7676280
• Report Number: 3006695864-2018-01479
• Device Sequence Number: 19184789
• Product Code: HQC
• UDI-Device Identifier: 05050474521148
• UDI-Public: (01)05050474521148(17)210115(10)4065973
• 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): 10/30/2020
• 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: 01/15/2021
• Device Model Number: OPOR3021G
• Device Catalogue Number: OPOR3021G
• Device Lot Number: 4065973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 10/11/2018; 10/25/2020
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 10/22/2018; 10/30/2020
• 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