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

Model Number	PCB00
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable as the lens was not implanted.If explanted, give date: not applicable as the lens was not implanted and therefore not explanted.This complaint is part of the recall - report number: 2020664-06/21/18-001-r.The investigation has identified the root cause of the inadvertent shipment to be a process error.The identification of expired material at the geodis distribution center relies on a daily-generated, manual report to identify and segregate short-dated and/or expired products.The daily report did not detect the product in question due to returned product being allocated to an allocable location (i.E., in a location able to be used for fulfilling customer orders) and being shipped the same day.The analysis concluded that when these two conditions occur in between generating a daily report, the opportunity exists for expired product to be shipped.There have been no illnesses or injury related to this issue.To prevent this issue from reoccurring immediate action was taken.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an expired intraocular lens (iol) was shipped to the customer.The lens was not used.No further information was provided.
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 (b)(4).

• Brand Name: TECNIS ITEC PRELOADED 1-PIECE IOL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC; santa ana CA
• MDR Report Key: 7668346
• Report Number: 2648035-2018-00957
• Device Sequence Number: 1329879
• Product Code: HQL
• UDI-Device Identifier: 05050474558069
• UDI-Public: (01)05050474558069(17)180205
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020
• 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: 02/05/2018
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2020664-06/21/18-001-R
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005