MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION TECNIS ITEC PRELOADED 1-PIECE IOL; MONOFOCAL IOLS

Model Number	PCB00
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Implant and explant dates: if implanted or explanted, give date: not applicable; there was no indication the lens was implanted; therefore, not explanted.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that intraocular lens had a bent haptic.Reportedly, the lens had patient contact.No further information provided.
Additional Manufacturer Narrative
Device evaluation: the returned pcb00 device was received in the packaging box.The plunger was in completely advanced position and locked.The pcb00 device was observed under microscope and a scarce amount of lubricant residue was observed inside the device.The lens was observed stuck and out at the end of the cartridge tip with the lead haptic out of the tip with the pushrod adhered.The complaint was not verified in the sample return; however, a lead haptic not folded condition was observed and could be related to the scarce amount of viscoelastic.No product quality deficiency was identified.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions 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 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 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.

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION; santa ana CA
• MDR Report Key: 7963249
• Report Number: 2648035-2018-01321
• Device Sequence Number: 202000
• Product Code: HQL
• UDI-Device Identifier: 05050474558168
• UDI-Public: (01)05050474558168(17)200116
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 10/23/2018; 10/25/2020
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 11/13/2018; 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005