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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vitrectomy (2643)
Date of Event	03/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that tecnis monofocal intraocular lens (model zcb00 +16.0 diopter) was removed from patient¿s right eye and the patient left aphakic.Additional information was received, and it was learnt that vitrectomy was performed.Patient was doing fine at discharge.No further information provided,.
Additional Manufacturer Narrative
Device available for evaluation; returned to manufacturer on: 4/30/2019.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection using magnification was performed to the returned sample.Traces of what appears to be viscoelastics are observed on the lens surface.The lens was cut; most probably related to the explant mentioned on the initial report.The lens borders are smooth.The haptics are undamaged.The reported issue could not be verified.Based on the information provided by the customer (indicates there was no product quality issue) and evaluation of the lens; there is no indication of a product quality deficiency.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints related to this production order was conducted in the complaint system.The search revealed no additional investigation requests has been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction data: in the initial report section implant date and explant date was inadvertently populated incorrectly.The correct data is as follows: if implanted, give date: not applicable, as lens was removed in the initial surgery.If explanted, give date: not applicable, as lens was removed in the initial surgery.All pertinent information available to johnson and johnson surgical vision 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 (b)(4) and capa-010215.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8490212
• Report Number: 2648035-2019-00434
• Device Sequence Number: 1471805
• Product Code: HQL
• UDI-Device Identifier: 05050474531635
• UDI-Public: (01)05050474531635(17)220627
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/10/2020
• 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: 06/27/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 05/02/2019; 06/23/2019; 10/25/2020
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 05/29/2019; 07/18/2019; 11/11/2020
• 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: CARTRIDGE MODEL 1MTEC30; CARTRIDGE MODEL 1MTEC30
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005