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 Code Available (3191)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: patient age/date of birth: unknown as information was not provided.If implanted, if explanted, give date: not applicable, as the intraocular lens was inserted and removed in the initial surgery.(b)(4).Device evaluation: product testing could not be performed because the product was discarded by the account.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed that one (01) additional investigation request (ir) for this production order number has been received and is not related to this complaint.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
While inserting the intraocular lens (iol) in the patient¿s ocular dexter (right eye) it was reported the plunger did not feed the lens out, the lens was stuck in the pre-loaded cartridge, and there was patient contact with the product.The incision was enlarged and the lens was discarded.No further information is available.
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-010215.

• 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: 10165653
• Report Number: 2648035-2020-00451
• Device Sequence Number: 19725951
• Product Code: HQL
• UDI-Device Identifier: 05050474558106
• UDI-Public: (01)05050474558106(17)211119
• 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
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000120
• 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: 06/10/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 06/17/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005