MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. AMO INFUSION SLEEVE AND TEST CHAMBER; PHACO ACCESSORY

Model Number	OPOS20L
Medical Device Problem Code	Flushing Problem (1252)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of birth is unknown as it was not provided.Patient gender is unknown as it was not provided.Reporter telephone: (b)(6).(b)(4).Although, the hospital is reporting this adverse event and did not request field service or clinical, the hospital conducted a culture test and reviewed cleaning and sterilization practices.The hospital will begin to clean instruments via ultrasonic cleaning, flushing instruments after each use and has switched to single used instead of re-usable accessories.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
A hospital reported a cataract patient was presented with toxic anterior segment syndrome (tass) when using a phaco handpiece, tips and sleeve.A brief description from the hospital that at a one-day follow up exam, it was noted the patient had inflammation lasting 24 hours.Antibacterial infusion and an anterior chamber wash were performed.A culture test was performed.The test found no bacteria was present, hence, the surgeon considered tass as the diagnosis.The cleaning and sterilization practices were reviewed.Previously, ultrasonic cleaning was not used, and a vacuum boiling type wash was used for decontaminating instruments.In the future, the tip and sleeve will be switched from reuse to single use.The accessories will be cleaned and sterilized.In addition, the hospital will begin thoroughly flushing out instruments after each case.It was reported the patient outcome is well and has recovered.The hospital indicated the handpiece, tips and sleeve will not be returned.This is 1 of 4 reports.This report is for the sleeve.Separate reports will be submitted for the handpiece and tips.
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.
Additional Manufacturer Narrative
B5: additional information was provided: the hospital will investigate the sterile materials currently in use at the facility and check for residuals in these products and it was unknown which product was used all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
H10: additional: although, the suspected opos20l, lot no.60146462 was not returned, as a proactive measure, the hospital returned 11 handpieces model 690880 with serial# (b)(6), 10 ia tip, straight,.3mm model opo1a20str and 2 solo ia tip, 45 deg,.3mm model opo1a2045d with no lot# for further evaluation.Visual inspection was performed, and no damage or foreign matter/debris were found.All returned devices were clean with no evidence that could be possibly contributed to the reported event of toxic anterior segment syndrome (tass).For the handpieces that had serial numbers listed a manufacturing record review was performed for the returned handpiece, and no related non-conformity or deviations were issued during manufacturing process.Device was manufactured and released within all specifications.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: AMO INFUSION SLEEVE AND TEST CHAMBER
• 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: 9455757
• Report Number: 3006695864-2019-00980
• Device Sequence Number: 19602428
• Product Code: HQC
• UDI-Device Identifier: 05050474500389
• UDI-Public: (01)05050474500389(17)210827(10)60146462
• 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,Followup
• Report Date (Section B): 11/04/2020
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: OPOS20L
• Device Catalogue Number: OPOS20L
• Device Lot Number: 60146462
• 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: 11/21/2019
• Supplement Date Received by Manufacturer: 12/18/2019; 01/29/2020; 10/25/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/09/2020; 02/19/2020; 11/04/2020
• 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: HANDPIECE AND TIPS.
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005