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 Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided; best estimate is between (b)(6) 2019 and (b)(6) 2019.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a pcb00 intraocular lens (iol) was implanted in the patient's operative eye on (b)(6) 2019.It was later explanted on (b)(6) 2019 because the patient could not adjust to single vision.Reportedly, patient is doing fine post surgery.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation, returned to manufacturer on: 10/16/2019.Device evaluation: the pcb00 lens was returned in a plastic bag.The sample was evaluated, and the lens was observed cut with residues that looks like body fluids on the lens related to the handling of the unit in a surgical procedure.The condition observed is consistent with a lens that has been explanted.The reported issue was not verified; however, lens cut was confirmed but it could not be determined if the condition observed is related to manufacturing process as the reported lens was used and cut in a surgical procedure.Based on the product returned evaluation, a product quality deficiency or product malfunction could not be determined.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 no other complaint has been received for this production order number.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: 9139115
• Report Number: 2648035-2019-01064
• Device Sequence Number: 14188388
• Product Code: HQL
• UDI-Device Identifier: 05050474558151
• UDI-Public: (01)05050474558151(17)220318
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2020
• 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: 03/18/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 10/17/2019; 10/25/2020
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 11/11/2019; 11/10/2020
• 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
• Date Report Sent to FDA: 01/01/2005