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

Model Number	ZCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Vitrectomy (2643)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Device evaluation: visual inspection under magnification was performed and viscoelastic residue was observed on the lens'' optic body and haptics.Additionally, the lens was observed to be cut in half, which is consistent with a lens that was handled during explant.The lens was cleaned and no cosmetic defects related to the haptics were observed.The complaint issue could not be verified, and no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.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.
Event or Problem Description
It was reported that the optic or haptic of the intraocular lens (iol) did not feel smooth.The iol was cut out, removed during the same procedure from the patient's right eye.The surgery was completed using a non-johnson & johnson replacement lens.A vitrectomy was required, however, there was no patient injury and no additional intervention required.No additional information was provided to johnson & johnson surgical vision.
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(b)(4).

• 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: 9722595
• Report Number: 2648035-2020-00156
• Device Sequence Number: 16974259
• Product Code: HQL
• UDI-Device Identifier: 05050474531833
• UDI-Public: (01)05050474531833(17)220524
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 11/03/2020
• 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: 76 YR
• Date Report Sent to FDA: 01/01/2005