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	08/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, not provided.Gender/sex: unknown, not provided.If implanted; give date: not applicable as the lens was removed/replaced within the initial procedure.If explanted; give date: not applicable as the lens was removed/replaced within the initial procedure.(b)(4).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 removed/replaced within the initial surgery due to being stuck in the cartridge with patient contact.An incision enlargement was required.Another lens, a model za9003 25.5 was implanted.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation; returned to manufacturer on: 9/26/2019.Device evaluation: the product was returned to the manufacturing site for evaluation.The product associated to the complaint was received at the complaint lab on 9/26/2019.Only the lens was returned cut in two pieces and pieces of the lens are missing.The lens was received in a plastic bag and stuck to a paper by what appears to be viscoelastics.The complaint was not verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed an additional investigation request for this production order number has been received.No product deficiency was identified as result of the investigation.Based on the product returned evaluation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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: 9114520
• Report Number: 2648035-2019-01040
• Device Sequence Number: 2811312
• Product Code: HQL
• UDI-Device Identifier: 05050474558410
• UDI-Public: (01)05050474558410(17)210522
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 10/15/2019; 10/25/2020
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 10/17/2019; 11/10/2020
• 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