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

Model Number	PCB00
Medical Device Problem Codes	Break (1069); Failure to Fold (1255)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender: unknown, information not provided.If implanted, give date: not applicable, as the lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted therefore it was not explanted.Device evaluation: the complaint product was returned in a plastic bag.All the components were observed correctly engaged.There were no assembly errors and/or defect related to manufacturing process.Th plunger was in a partially advanced position.Traces of lubricating material was observed in the device.The lens got stuck at the cartridge tip and it looks torn.Piece of lens was missing.Due to the condition of the sample returned reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.There are no discrepancies found during the mrr (manufacturing record review).The search revealed no additional complaints from this production order number.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.
Event or Problem Description
It was reported that the leading haptic was not folded correctly.There was no patient contact.This event was reported during handling and prior to insertion into the eye.The device evaluation found the lens got stuck at the cartridge tip and it looks torn;piece of lens was missing.No further information available.

• 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: 11514735
• Report Number: 2648035-2021-00039
• Device Sequence Number: 4203759
• Product Code: HQL
• UDI-Device Identifier: 05050474558168
• UDI-Public: (01)05050474558168(17)220528
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• 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
• Report Date (Section B): 03/18/2021

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: 05/28/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1