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 Codes	Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	08/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as the lens was inserted and removed.If explanted, give date: not applicable, as the lens was inserted and removed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient's capsular bag tore after a pcb00 28.0 diopter lens was implanted in the patient's left eye (od).Therefore, the lens was removed, a vitrectomy was performed, and the replacement lens was a non-johnson and johnson lens.There was no incision enlargement or sutures used.Reportedly, there was no patient injury and the patient is doing fine post-operatively.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 08/28/2018.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The plunger was observed in advanced position.The plunger was gently pulled back and found locked.The pcb00 device was observed under microscope and traces of viscoelastic were observed at the cartridge tip.There were no damages observed on the assembly, neither flashes (screw thread and nut thread were found without damages).There are indications of coating observed at the cartridge canopy.There is no visible gap.The lens was observed stuck at the cartridge.There is no damage on the cartridge tip.The reported issue could not be verified.Based on the product returned evaluation a product quality deficiency or product malfunction could not be determined.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no additional complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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 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.; santa ana CA
• MDR Report Key: 7892153
• Report Number: 2648035-2018-01252
• Device Sequence Number: 14134533
• Product Code: HQL
• UDI-Device Identifier: 05050474558427
• UDI-Public: (01)05050474558427(17)210612
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 11/03/2020
• 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: 06/12/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 10/01/2018; 10/25/2020
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 10/03/2018; 11/03/2020
• 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: 75 YR
• Date Report Sent to FDA: 01/01/2005