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 Codes	Visual Impairment (2138); Vitrectomy (2643); No Code Available (3191)
Date of Event	04/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that post implant of the intraocular lens (iol) the patient was impacted with decreased visual acuity and myopic outcome after cataract surgery.There was a vitrectomy performed and a suture was placed.Suture was noted as standard procedure for this case.There was no incision enlargement required.The replacement lens was the same model but a lower diopter.The patient was reported to be doing fine when discharged.Visual acuity pre-op (pre-initial implant): 20/40 (with glasses); visual acuity post-op (post-initial implant):20/60; visual acuity post-op (post-replacement):20/25+2.No other information provided.
Additional Manufacturer Narrative
Device evaluation: lens is not available for investigation.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search performed on complaints revealed no additional investigation requests for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and 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(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: 8694524
• Report Number: 2648035-2019-00637
• Device Sequence Number: 19305092
• Product Code: HQL
• UDI-Device Identifier: 05050474531871
• UDI-Public: (01)05050474531871(17)220817
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020
• 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: 08/17/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 06/17/2019; 10/25/2020
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/15/2019; 11/12/2020
• 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: 72 YR
• Date Report Sent to FDA: 01/01/2005