MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; TORIC IOLS

Model Number	ZCT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	07/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, the lens was removed/replaced within the initial procedure.If explanted, give date: not applicable, the lens was removed/replaced within the initial procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after the tecnis toric intraocular lens (iol) was fully inserted, when the surgeon was rotating the lens into position, it cut through the patient's capsular bag.A vitrectomy was required and the iol was removed and replaced with a non-johnson and johnson lens.Reportedly, patient has recovered post surgery.No additional information provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 10/21/2020.Device returned to manufacturer: yes.Device evaluation: the product was received in the original lens case.The original folding carton, patient stickers, implant notification card, and additional documentation were received as well.Visual inspection under magnification revealed a detached haptic, viscoelastic residue on the optic body and haptic, and that the lens was received cut in half, which is consistent with a lens handled during removal and replacement.Based on the return condition of the lens, no further 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 specification.Historical data analysis: a search of complaints revealed no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a quality product 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
• 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: 10745263
• Report Number: 9614546-2020-00462
• Device Sequence Number: 19618112
• Product Code: HQL
• UDI-Device Identifier: 05050474552692
• UDI-Public: (01)05050474552692(17)210228
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: 02/28/2021
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 12/07/2020
• 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: PLATINUM CARTRIDGE, 1MTEC30, LOT UNKNOWN; PLATINUM CARTRIDGE, 1MTEC30, LOT UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR