MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS TORIC II 1-PIECE ACRYLIC; TORIC IOLS

Model Number	ZCU450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: breakdown of 1 events is as follows: cosmetic issues 1.Serial number of the suspect product: (b)(4), 1.1 investigation were completed, and 0 investigations are pending from this period.Breakdown of 1 completed investigations: (b)(4), lens cut.The investigation concluded that the product met manufacturing release criteria.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
This report summarizes 1 malfunction events.The events were related to lens damage.There were no patient injuries reported associated to the events.

• Brand Name: TECNIS TORIC II 1-PIECE ACRYLIC
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 11256546
• Report Number: 9614546-2021-00005
• Device Sequence Number: 3256137
• Product Code: HQL
• UDI-Device Identifier: 05050474662988
• UDI-Public: (01)05050474662988(17)250723
• Combination Product (Y/N): Y
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/31/2021

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: No Information
• Device Model Number: ZCU450
• Device Catalogue Number: ZCU450U140
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2021
• Patient Sequence Number: 1