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

Model Number	PCB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.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 the intraocular lens (iol) had a notch in the lens.The iol was cut out, removed during the same procedure and the surgery was completed successfully using a non-johnson & johnson replacement lens.There was no vitrectomy, incision enlargement or sutures required.Reportedly, the patient is doing fine.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Device evaluation: the preloaded delivery system, model pcb00, was returned at the manufacturing site for evaluation.The plunger was observed in advanced position and locked.The pcb00 device was observed under the microscope and trace of viscoelastic was observed only at the cartridge.Dfu (directions for use) states to completely fill the viewing window of the pcb00 with ovd (ophthalmic viscosurgical device).No molding damages/defects or flashes were observed on the cartridge.There were no damages observed on the assembly.The intraocular lens (iol) was not returned therefore the customer's reported issue could not be verified.A product quality deficiency could not be determined.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no similar complaints for this order number have been received.Labeling review: the dfu was reviewed.The dfu adequately provides instructions and 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.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: 8387420
• Report Number: 2648035-2019-00276
• Device Sequence Number: 18910327
• Product Code: HQL
• UDI-Device Identifier: 05050474558175
• UDI-Public: (01)05050474558175(17)210305
• 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: Other
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/05/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 03/07/2019; 10/25/2020
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 04/02/2019; 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005