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

Model Number	PCB00
Medical Device Problem Codes	Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012); Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The intraocular lens was not implanted.If explanted; give date: n/a (not applicable).The intraocular lens was not implanted.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a model pcb00 monofocal iol (intraocular lens) did not leave the injector as the plunger ripped through the cartridge wall.When the doctor took the lens out, the lens was missing the haptic.The issue was first noticed while the lens was being implanted.A new lens was used instead.No additional information provided.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no additional complaint for this order number have been received.Labeling review: the directions for use (dfu) were reviewed, the dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device available for evaluation: yes, returned to manufacturer on: 05/31/2019.Device returned to manufacturer: yes.Device evaluation: the pcb00 product was received in original packaging (folding carton).A visual inspection and evaluation using magnification was performed.The plunger and pushrod were observed in advanced position.No assembly error and/or defect were observed in the preloaded device related to manufacturing process.Residues of viscoelastic material was observed on cartridge.The cartridge tip was observed cracked and a piece of haptic was observed stuck.The returns include also: lens and, lens case.The lens was visual inspected, and the findings were: residues, particles were in lens surface also, a haptic detached was observed.The other haptic look complete with good conditions.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.The complaint issue was verified.However, there is no evidence to suggest that the complaint sample has been affected by the manufacturing process.No product deficiency was identified.Conclusion: as a result, of the investigation there is no indication of a product malfunction or 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.; santa ana CA 92705
• MDR Report Key: 8238320
• Report Number: 2648035-2019-00058
• Device Sequence Number: 11158809
• Product Code: HQL
• UDI-Device Identifier: 05050474558076
• UDI-Public: (01)05050474558076(17)200512
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/06/2020
• 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: 05/12/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 03/26/2019; 06/06/2019; 10/25/2020
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 04/25/2019; 06/18/2019; 11/06/2020
• 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