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 Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, the lens was not implanted.If explanted, give date: not applicable, the lens was not implanted.Device evaluation: the product testing could not be performed as the product was discarded and not returned.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the review.The product was manufactured and released according to specifications.The search revealed 2 other complaint for this production order number was received.No product deficiencies were determined.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that haptic broke off from preloaded intraocular lens while inserting.There was patient contact with the lens.Reportedly there was no incision enlargement, no vitrectomy required.Patient was doing fine when discharged.The complaint lens was discarded by the surgery center.No further information provided.
Additional Manufacturer Narrative
Correction: in follow up 1, it was incorrectly stated that lens remains implanted.The lens was explanted and lens with model pcb00 was used as replacement for the patient.Following sections are also corrected as it was inadvertently entered incorrectly.(b)(4).If implanted: in the first follow up mdr it was reported that the lens was not removed and remains implanted with implant date as (b)(6) 2019, however the lens was actually explanted in secondary surgical procedure.If explanted, give date: unknown.(b)(4).Device evaluation comment provided in follow-up #1 is now updated to; the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.All pertinent information available to johnson and johnson surgical vision has been submitted.
Additional Manufacturer Narrative
Additional information: it was learnt that the lens was not removed and replaced in the same procedure.The lens was left in the patient's operative eye.However doctor was scheduled to bring back the patient for secondary surgical procedure to explant the lens.No further information provided.(b)(4).Corrected data: if implanted: in the initial mdr it was reported that the lens was removed/ replaced in same procedure.However the lens was not removed and remains implanted with implant date as (b)(6) 2019.If explanted, give date: not applicable, as the lens remains implanted.(b)(4).In the initial mdr it is noted under device evaluation that product testing could not be performed as the product was discarded and not returned.This comment is now being updated to: device evaluation: the product testing could not be performed as the product was not returned because the lens remains implanted.The reported complaint cannot be confirmed.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: 8326630
• Report Number: 2648035-2019-00173
• Device Sequence Number: 1788902
• Product Code: HQL
• UDI-Device Identifier: 05050474558199
• UDI-Public: (01)05050474558199(17)211002
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000165
• 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: 01/15/2019
• Supplement Date Received by Manufacturer: 02/12/2019; 10/13/2019; 10/25/2020
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/08/2019; 11/07/2019; 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005