MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. SOLO; CANNULA, OPHTHALMIC

Model Number	OPOIA20STR
Medical Device Problem Codes	Break (1069); Sharp Edges (4013)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	07/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Phone #: (b)(6).Lot#: unknown/not provided.Expiration date: unknown as product lot number was not provided.Udi #: a complete udi # is unknown as product lot number was not provided.Device manufacture date: unknown, as the lot number of the device was not provided.Device has not returned.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that posterior capsule rapture occurred while surgeon was polishing with the irrigation/aspiration handpiece during procedure.An anterior vitrectomy was performed and procedure was successfully completed.It was alleged that the handpiece tip might have had burrs.
Additional Manufacturer Narrative
Additional information: d4 - lot number 113455 and udi (b)(4).D9.Returned to manufacturer on: october 21, 2021.H3.Device evaluated by manufacturer? yes.H6: investigation codes: 10, 3331.H6: investigation findings: 115.H6: investigation findings: 61.Device evaluation: account reported 1 event however there were 2 devices returned.Both devices were evaluated.This is the first complaint for this lot.One of the devices is bent at the base of the cannula.The port was visibly clogged.The port was also damaged with multiple gouges on the edges.The port on the second device was also damaged.There was a dent/crack at the distal end of the port.It's obvious on both devices that something has been forced into the port so much so that it has indented the cannulas and created a burr on the port of one device and a crack on the edge of the port on the other.It is possible that if the device was not cleaned after surgery it could lead to cortical material hardening in the cannula and the port.It is also possible that the damage observed was caused in an attempt to unclog the handpiece and the port.These devices should be inspected before each use for damage.The handles should be soaked in sterile distilled water immediately after use per instructions in the directions for use.The observations made indicate mishandling of device.
Additional Manufacturer Narrative
Correction: section h6: as part of an internal review of our mdrs it was identified that the medical device problem code(s) 4013 was not included, the health effect impact code 4632 was not included and the component codes 4755 and 3067 were not included.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: SOLO
• Common Device Name: CANNULA, OPHTHALMIC
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12362362
• Report Number: 2020664-2021-07173
• Device Sequence Number: 4115543
• Product Code: HMX
• UDI-Device Identifier: 05050474521070
• UDI-Public: (01)05050474521070(10)UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2022

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: OPOIA20STR
• Device Catalogue Number: OPOIA20STR
• Device Lot Number: 113455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/08/2021; 10/21/2022
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 12/08/2021; 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown