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

Model Number	PCB00
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.(b)(4).If implanted; give date: unknown/not provided.If explanted; give date: unknown/not provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during a cataract surgery, an intraocular lens, model pcb00 got stuck in the cartridge during implantation.Haptic was in contact with the patient eye due the fact that the lens was partly out of the cartridge.No patient injury reported.No further information available.
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 (b)(4) and capa-010215.
Additional Manufacturer Narrative
Section d10: device available for evaluation? yes, returned to manufacturer on 12 december 2019.Section h3: device returned to manufacturer, yes.Device evaluation: the product associated to the complaint was received 12 december 2019.The returned device, model pcb00, was received in a plastic bag.The plunger was advanced for delivery and found locked and functional.The pcb00 device was observed under microscope and no traces of viscoelastic were observed in the cartridge.The reported stuck in cartridge was verified.There were no damages on the assembly, there was no visible gap.The assembly of the device returned was found correct.Based on the product returned evaluation there was no indication of a product quality deficiency.The reported complaint was not confirmed.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no additional investigation request (ir) for this order number have been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.H3 other text : placeholder.

• 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: 9456069
• Report Number: 2648035-2019-01315
• Device Sequence Number: 3072598
• Product Code: HQL
• UDI-Device Identifier: 05050474558380
• UDI-Public: (01)05050474558380(17)190607
• Combination Product (Y/N): Y
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 12/24/2019; 10/25/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/16/2020; 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005