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

Model Number	PCB00
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a preloaded intraocular lens (iol) was inserted in the patient's eye and was then removed as the iol flipped.The surgeon had to cut the lens up to remove it from the eye, and it was replaced with a back-up iol of the same model and diopter.There was no patient injury but reportedly sutures were required.No further information is provided.
Additional Manufacturer Narrative
Additional information: section d10: device available for evaluation ¿ yes, returned to manufacturer on 10/12/2020.Section h3: device returned to manufacturer ¿ yes device evaluation: complaint product was returned in its original packaging.Upon evaluation of the device the plunger was observed in a fully advanced position.All the components look correctly engaged to the device.No assembly error and/or defect related to the manufacturing process was observed.Visual inspection performed under microscope: a small amount of lubricating material was observed in the device.There was no lens was received inside nor outside the device.Based in the analysis of the sample returned there was nothing identified that may lead to the reported issue.The complaint reported could not be verified.There was no product quality deficiency identified.Manufacturing records review: the manufacturing records for the device were reviewed.There was no discrepancy and/or deviation found during the mrr (manufacturing record review).The product was manufactured and released according to specification.A search in complaint system revealed two additional complaints were received from this production order and complaints meet the criteria for no further investigation per johnson & johnson surgical vision complaint handling procedures.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.

• 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: 10640097
• Report Number: 2648035-2020-00743
• Device Sequence Number: 2901266
• Product Code: HQL
• UDI-Device Identifier: 05050474558212
• UDI-Public: (01)05050474558212(17)230119
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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
• Report Date (Section B): 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/19/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 11/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention