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

Model Number	PCB00
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that while inserting a pcb00, 13.0 diopter intraocular lens (iol) into the lens into the patient¿s left eye a capsule tear occurred.An anterior vitrectomy was required, and the lens was removed and replaced with a sulcus lens, however no incision enlargement was required.Through follow-up it additional details were provided.After insertion the lens was noted to decenter and the posterior capsule tear was discovered.The lens was cut out and removed.The replacement lens was a za9003 that was noted to be scratched after insertion and was removed and replaced with a second za9003 lens.One-week post exchange the patient was seen for a retinal detachment and decreased vision, but no retinal surgeries were noted.Patient was monitored until stable.
Additional Manufacturer Narrative
Per post market surveillance officer, consultation, the posterior capsule tear with subsequent vitreous prolapse requiring vitrectomy increase the risk of retinal detachment during cataract surgery.Saying that, retinal detachment was probably related to the surgical complication during pcb00 implant in this event.Based on the review provided, additional patient code provided: retinal detachment.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: a packaging box of a pcb00 was received.There was a surgical pouch with a lens inside.The lens was observed under microscope and it was observed cut.This condition is typical of a lens that has been explanted or removed.The complaint could not be verified due the condition of how the lens was returned.A product quality deficiency could not be verified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.Labeling review: the labeling review was completed.The directions for use (dfu) adequately provide instructions, precautions, along with warnings for the proper use and handling of the product.Conclusion: as a result of the investigation there is no indication of a product quality 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 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: 8467982
• Report Number: 2648035-2019-00402
• Device Sequence Number: 19198935
• Product Code: HQL
• UDI-Device Identifier: 05050474558120
• UDI-Public: (01)05050474558120(17)210826
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 11/10/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 03/21/2019; 04/29/2019; 10/25/2020
• Initial Report FDA Received Date: 03/31/2019
• Supplement Report FDA Received Date: 04/17/2019; 05/24/2019; 11/11/2020
• 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: 76 YR
• Date Report Sent to FDA: 01/01/2005