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

Model Number	ZCU375
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	10/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as the lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted; therefore, it was not explanted.(b)(4).Device evaluation: product evaluation cannot be performed as per the initial report, the lens has been discarded.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that 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.
Event or Problem Description
It was reported that the intraocular lens (iol) was removed and replaced from a study patient due to loose zonules and vitreous in the anterior chamber.It was learned that the event was not iol related.Nevertheless, there was vitrectomy and incision enlargement.Post-op day 1 the patient had scattered hyphema and significant corneal edema.Uncorrected distance visual acuity (ucdva) at day 1 was hand motion (hm).At follow-up exam, hyphema was still present, and corneal edema but had improved however, ucdva was still at hm.Intraocular pressure (iop) was elevated to 34mmhg due to hyphema.Started subject on ocular hypotensive medications.Visual acuity (va) was still hm and hyphema and elevated iop were no improvement.Hence, the subject was referred to a glaucoma specialist.The lens was reported to be discarded on site.No other information was provided.

• 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: 10797037
• Report Number: 9614546-2020-00473
• Device Sequence Number: 2954025
• Product Code: HQL
• UDI-Device Identifier: 05050474700574
• UDI-Public: (01)05050474700574(17)241031
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: ZCU375
• Device Catalogue Number: ZCU375U205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 11/05/2020
• 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: 69 YR