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

Model Number	PCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age/date of birth: unknown as information was not provided.Patient gender: unknown as information was not provided.If implanted, if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Reported lens damage was captured in january 2020 vmsr reporting.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
During implantation of pcb00 17.0 diopter intraocular lens (iol) into the patient¿s operative eye, account reported the trailing haptic was amputated (detached).The doctor was able to exchange the iol without incident and kept the bag intact.Through follow up, customer account provided additional information confirming no incision enlargement, no serious patient injury, no vitrectomy, and patient outcome was reported as no negative outcome.It was reported that a 10-0 nylon suture was used and the same procedure was completed using a zcb00 17.0 diopter iol as the replacement lens.Reported lens damage was captured in january 2020 vmsr reporting.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional information: device available for evaluation; returned to manufacturer on: 02/19/2020.Device evaluation: it was returned in its original packaging with a sample container.The plunger was in a partially advanced position.The cartridge was correctly engaged to the device.No assembly error and/or defect related to manufacturing process were observed.Visual inspection performed under microscope magnification: scarce amount of lubricant material residue was observed in the device.Two lenses were received inside the sample container.Both were cut in half and lacked a haptic.These could be related to the replacement process.The reported issue was verified, however, due to the condition in which the sample returned it is not possible to determine the reported issue is related to the manufacturing process.Based in the analysis, product quality deficiency could not be determined.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 revealed that no additional complaints for this production order number have been received.Conclusion: as a result, of the investigation, there is no indication of a product malfunction or product quality deficiency.The reported issue was not 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 nr-0148919 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: 9697301
• Report Number: 2648035-2020-00127
• Device Sequence Number: 14142224
• Product Code: HQL
• UDI-Device Identifier: 05050474558205
• UDI-Public: (01)05050474558205(17)220924
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2020
• 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: 09/24/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 02/13/2020; 10/25/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 02/27/2020; 11/04/2020
• 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