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

Model Number	ZCU225
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 event is as follows: device partially delivered, haptic damaged 1.Serial number of the suspect product: (b)(4).Zero investigations have been completed and 1 investigation is pending from this period.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Site address: (b)(4).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.
Additional Manufacturer Narrative
Correction: this correction mdr is to address missing information in section h6,evaluation codes reported in the initial submission.Method: was left blank and should have been 4114.Results: was left blank and should have been 3233.Additional information: we have subsequently received the investigation results for serial number (b)(6).Device evaluation: no complaint lens was received; therefore, no product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no other complaints were received for this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.That was received during the time period that covers this voluntary malfunction summary report has been submitted.

• 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: 10767120
• Report Number: 9614546-2020-00466
• Device Sequence Number: 14299104
• Product Code: HQL
• UDI-Device Identifier: 05050474658783
• UDI-Public: (01)05050474658783(17)240910
• 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,Followup
• 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: Health Professional
• Device Expiration Date: 09/10/2024
• Device Model Number: ZCU225
• Device Catalogue Number: ZCU225U105
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2020
• Supplement Report FDA Received Date: 01/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1