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	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Not applicable, as lens was removed/replaced in the initial surgery.Not applicable, as lens was removed/replaced in the initial surgery.Email address unknown, information not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was partially inserted into the patients right and would not advance from the inserter.The procedure was completed with another iol of the same model and diopter.The patient has recovered.No additional information was reported.
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
Section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: 12/23/2019.Section h3: device returned to manufacturer: yes.Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for evaluation.Visual inspection using magnification was performed to the returned sample.No damaged was observed to the cartridge.No damaged was observed to the lens.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.The complaint issue reported could not be verified.Based on the analyzed of the returned, there is no indication of product quality deficiency.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no additional investigation requests have been received for this production order number.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: 9485264
• Report Number: 2648035-2019-01350
• Device Sequence Number: 459775
• Product Code: HQL
• UDI-Device Identifier: 05050474558144
• UDI-Public: (01)05050474558144(17)220509
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2020
• 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: 05/09/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 01/08/2020; 10/25/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/10/2020; 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Date Report Sent to FDA: 01/01/2005