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

Model Number	ZCU225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Therapeutic Effects, Unexpected (2099); No Code Available (3191)
Date of Event	10/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted.The patient is slightly hyperopic postoperative, likely from her lens sitting a little further back because she has a big bag from high myopia.The lens did not rotate, her lens is aligned properly.Through follow-up it was learned that the patient's pre-op best corrected distance visual acuity (bcdva) was 20/60 pinhole (ph) 20/25 in the left eye.Patient is slightly hyperopic post-op, explanting the lens with a higher power (21.0) to help correct for this.At exchange there was no capsule tear, no incision enlargement, no vitrectomy, and no sutures required.Post-op uncorrected distance visual acuity (ucdva) 20/20, bcdva 20/20 at 1 week post op on (b)(6) 2020.No other information was provided.
Additional Manufacturer Narrative
Additional information: device evaluation: product evaluation was not performed because the product has not yet been received.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that there was no discrepancy found during the review.The product was manufactured and released according to specifications.A search revealed that no other complaints were received from 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.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: 11099366
• Report Number: 9614546-2020-00545
• Device Sequence Number: 11727301
• Product Code: MJP
• UDI-Device Identifier: 05050474658967
• UDI-Public: (01)05050474658967(17)240918
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/18/2024
• Device Model Number: ZCU225
• Device Catalogue Number: ZCU225U195
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/31/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 02/19/2021
• 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: 74 YR