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 Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: lens was not implanted.If explanted; give date: lens was not implanted, therefore not explanted.(b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was been reported that the lens was defective.Through follow-up it was learned that the lens got stuck in the injector at the cartridge tip and haptic/optic contacted patient's eye.No secondary surgery/medical intervention was required.The iol was removed and replaced in the same procedure.Visual acuity (va) pre-op was reported as 0.5, and post-op va is 1.0.No additional information was provided.
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.
Additional Manufacturer Narrative
Device evaluation: product testing could not be performed since the product was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that one additional complaint was received from this production order for empty package and there is no indication of malfunction or product quality deficiency.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.
Additional Manufacturer Narrative
Additional information per ir results: device available for evaluation ¿ yes, returned to manufacturer on 1/29/2020.Device returned to manufacturer ¿ yes.Device evaluation: the complaint product was returned in its original packaging.The plunger was in a partially advanced position.The cartridge was correctly engaged to the device.No assembly error and/or defect related to manufacturing process were observed.Visual inspection at microscope magnification was performed: lubricant material residue was observed in the device.Cartridge tip was damaged/deformed.The lens was stuck in the inserter and pushrod overrides it.The reported issues of stuck in cartridge was not verified.Based on the analysis, there is not product quality deficiency identified.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.

• 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: 9339557
• Report Number: 2648035-2019-01217
• Device Sequence Number: 19379182
• Product Code: HQL
• UDI-Device Identifier: 05050474558212
• UDI-Public: (01)05050474558212(17)211201
• Combination Product (Y/N): Y
• Initial Reporter Country: ES
• 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,Followup
• Report Date (Section B): 11/05/2020
• 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: 12/01/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 12/20/2019; 02/05/2020; 10/25/2020
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 01/13/2020; 03/05/2020; 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005