MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC SOLO; CANNULA, OPHTHALMIC

Model Number	OPOIA20STR
Medical Device Problem Codes	Break (1069); Sharp Edges (4013)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age or date of birth, weight and ethnicity not provided.Date of event - unknown / not provided.(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
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): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12362405
• Report Number: 2020664-2021-07184
• Device Sequence Number: 3822148
• 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
• 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: UNKNOWN
• 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: 10/21/2022
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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