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

Model Number	PCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vitrectomy (2643)
Date of Event	10/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no additional complaint folders for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient required a vitrectomy with an intraocular lens (iol) that may have been fully inserted and removed in the same procedure.The lens was discarded.The patient is doing fine.No additional information was provided to johnson & johnson surgical vision.

• 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: 11025157
• Report Number: 2648035-2020-00941
• Device Sequence Number: 19704716
• Product Code: HQL
• UDI-Device Identifier: 05050474558359
• UDI-Public: (01)05050474558359(17)221027
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• Report Date (Section B): 12/16/2020

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: 10/27/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000245
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 12/17/2020
• 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
• Patient Age: 67 YR