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

Model Number	PCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	03/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; if explanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was removed and replaced with a 3-piece za9003, serial number (b)(4) iol during the initial procedure, because of an unplanned vitrectomy.The patient outcome is unknown.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation; returned to manufacturer on: 6/17/2020.Device evaluation: the product was received in a plastic bag.The plunger was observed in a fully advanced position and pushrod was bent and exposed out of the cartridge tip.Cartridge was correctly engaged to the device.No assembly error and/or defect related to the manufacturing process was observed in the device.Visual inspection at microscope magnification: small amount of lubricating material residues was observed in the device.The lens was received out of the device.It was cut in pieces, and one of the haptic was broken.According to the information provided the reported issue is not related to the device.Based on the analysis there is no indication of product quality deficiency.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed two additional complaints were received from this production order; however, they are not related to the reported event.Conclusion: as a result of the investigation, there is no indication of a quality product 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 (b)(4) and capa-010215.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• 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: 10151336
• Report Number: 2648035-2020-00449
• Device Sequence Number: 13997569
• Product Code: HQL
• UDI-Device Identifier: 05050474558243
• UDI-Public: (01)05050474558243(17)221020
• Combination Product (Y/N): Y
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2020
• 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: 10/20/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 06/19/2020; 10/25/2020
• Initial Report FDA Received Date: 06/13/2020
• Supplement Report FDA Received Date: 06/25/2020; 10/30/2020
• 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