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

Model Number	PCB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: the customer initially reported lens scratched upon insertion without any visual symptoms identified on (b)(6) 2020; therefore, the lens scratch is submitted under vmsr malfunction report for first quarter 2020.Additional information was received on 4/16/2020 stating the patient is experiencing glare; therefore, the event is being submitted for adverse event reporting.Date of event: unknown, not provided.The best estimate onset date for glare would be between (b)(6) 2020.If explanted, give date: not applicable, the lens remains implanted.(b)(4).Device evaluation: the lens remains implanted; therefore, the complaint issue reported was not verified.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 one additional investigation requests have been received for this production order number but not related to this complaint.A product deficiency was not identified.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.
Event or Problem Description
The surgeon initially reported that he noticed a pcb00 intraocular lens was deeply scratched at the time of surgery, and thought that it would not negatively impact patient's vision as the scratch was not central located.He was not certain if this was related to a manufacturing related issue, or human error during the lens preparation, loading or deployment process.Additional information received through follow up reported that the patient complains of having significant glare post surgery.The patient is scheduled for an iol exchange once covid-19 quarantine ends.No further information provided.
Additional Manufacturer Narrative
Corrected data: in the initial mdr, catalog number was inadvertently left blank.Catalog number is pcb0000180.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.Other text : placeholder.
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 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: 10002470
• Report Number: 2648035-2020-00391
• Device Sequence Number: 19600713
• Product Code: HQL
• UDI-Device Identifier: 05050474558229
• UDI-Public: (01)05050474558229(17)221019
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• 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: 10/19/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000180
• 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: 04/16/2020
• Supplement Date Received by Manufacturer: 04/27/2020; 10/25/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 04/28/2020; 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: Other
• Date Report Sent to FDA: 01/01/2005