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

Model Number	ZCU300
Medical Device Problem Codes	Material Fragmentation (1261); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: product testing could not be performed since the product was not returned for evaluation (discarded).Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that another complaint was received from this production order.However, the complaint issues were not related.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the haptic of the intraocular lens sheered off upon insertion into the patient's right eye.The iol was centered and hence doctor left it in the eye.During one day post-op examination, it was examined that the iol had decentered.The iol was explanted and a new lens of different model (sn: (b)(4)) was implanted.There was no injury to the patient during the process, however, incision was enlarged with suture placement to close the wound.The patient is doing well post-op with uncorrected vision 20/25.No further information is available.

• 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: 10691537
• Report Number: 9614546-2020-00450
• Device Sequence Number: 3281929
• Product Code: HQL
• UDI-Device Identifier: 05050474660014
• UDI-Public: (01)05050474660014(17)250227
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2020

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 Expiration Date: 02/27/2025
• Device Model Number: ZCU300
• Device Catalogue Number: ZCU300U130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR