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

Model Number	ZA9003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: not applicable as the lens was inserted and removed.If explanted; give date: not applicable as the lens was inserted and removed.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that when inserting the intraocular lens (iol) za9003 into the patient's operative eye, the lens had a bent haptic.No medical intervention was required.A replacement lens of the same model and diopter was used.Additional information received stated that there was no patient injury and the patient was doing fine post-op.The complaint iol was discarded by the customer.No additional information was provided.
Additional Manufacturer Narrative
The device was initially reported as discarded in the initial mdr, however it was later received and evaluated.Therefore, the following fields have been updated accordingly; device available for evaluation: yes.Returned to manufacturer on: 11/21/2018.Device returned to manufacturer: yes.Device evaluation: visual inspection using magnification was performed on the returned sample.Loose fibers/particles were observed on lens related the handling of the unit out of a sterile environment.Residues of viscoelastic material was observed on lens.One part of the lens edge was observed bend.Both haptics was also observed distorted.The condition in which the sample returned is consistent with a lens that was implanted and removed.The complaint issue reported was verified.Based on the analyzed of the returned, there is no indication of product quality deficiency.(b)(4).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: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8050136
• Report Number: 2648035-2018-01448
• Device Sequence Number: 1787729
• Product Code: HQL
• UDI-Device Identifier: 05050474528932
• UDI-Public: (01)05050474528932(17)190822
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• 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
• Report Date (Section B): 11/04/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2019
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 11/26/2018; 10/25/2020
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 12/21/2018; 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005