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

Model Number	ZCT300
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	09/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: not applicable as lens was removed/replaced within the initial procedure.If explanted; give date: not applicable as 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 a zct300 20.5 diopter intraocular lens (iol) was inserted and then removed because the patient's chamber was weak and would not hold the lens.A vitrectomy was required.Via follow-up the customer said that there didn't appear to be anything wrong with the lens.The patient has a weak anatomy.A backup iol was used to complete the procedure.The customer later followed-up to provide more detailed information.The lens was injected into the capsular bag.It was difficult to keep the bag open when inserting the lens.Additional viscoelastic was injected around the lens.Even with this, the lens seemed to drag on the capsule.The iol was inserted and viscoelastic was irrigated and it was very difficult to remove behind the lens.The anterior chamber was injected with balanced salt solution and when rotating the iol it was noted that the posterior capsule was opened.The decision was made to remove the toric iol as there was not enough capsular support for the lens.Additional viscoelastic was used to deepen the chamber.Micro scissors and graspers were used to hold and cut the lens.The lens was removed without problems.An anterior mechanical vitrectomy was done without problems.A monofocal lens model za9003 20.0 diopter was folded and placed in the sulcus with optic capture in the capsulotomy.No further information was provided.
Additional Manufacturer Narrative
Corrected data: in follow-up #1 method code 4117 was provided, however, this was not the appropriate method code.The code should have been 4114 as the device had not been returned at that time.Additional information: device available for evaluation, yes.Returned to manufacturer on, 10/07/2019.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.A visual inspection of the returned lens shows it was cut in two pieces, most probably to aid in the explant.Based on the condition of the return, further analysis is not possible.The reported complaint event could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for 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.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• 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: 9137901
• Report Number: 3011852734-2019-00184
• Device Sequence Number: 11436437
• Product Code: MFK
• UDI-Device Identifier: 05050474553330
• UDI-Public: (01)05050474553330(17)210802
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/09/2020
• Report Date (Section F): 01/01/2005

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: 08/02/2021
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 10/10/2019; 10/22/2019; 10/25/2020
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 10/14/2019; 10/22/2019; 11/10/2020
• 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: 88 YR
• Date Report Sent to FDA: 01/01/2005