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

Model Number	ZCU450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	09/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, the lens remains implanted to date.The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that toxic anterior segment syndrome (tass) occurred in the left eye of a patient which was implanted with an intraocular lens.Moxifloxacin ophthalmic eye drops were given as a normal pre and post regimen.The patient was also taking durezol eye drops every 1-2 hours.In addition, the patient was given a medrol dose pak 4mg tablets po (use as directed) on (b)(6) 2020 post surgery.It was noted that the patient has recovered.The lens remains in the patient's eye.The account indicated that they have been doing an investigation and at this point they do not know where the tass is coming from.No further information was provided.This emdr report is for the intraocular lens, model zcu450.A separate emdr will be submitted for the healon endocoat device.
Additional Manufacturer Narrative
Additional information/corrected data: additional information received indicated that the post-op drops given to the patient were moxifloxacin, ketorolac, prednisolone.Also, initially the account reported ''(b)(6)1950'' to be the date of birth for the patient which was entered in the initial emdr report.However, additional information received from the account clarified that the correct date of birth for the patient is ''(b)(6) 1950''.Therefore the following field was updated accordingly.Section a2: age/date of birth: (b)(6) 1950.All pertinent information available to johnson and 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: 11062281
• Report Number: 9614546-2020-00534
• Device Sequence Number: 19492117
• Product Code: HQL
• UDI-Device Identifier: 05050474663091
• UDI-Public: (01)05050474663091(17)250709
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

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: 07/09/2025
• Device Model Number: ZCU450
• Device Catalogue Number: ZCU450U195
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 01/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEALON ENDOCOAT, LOT 028612
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR