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

Model Number	PCB00
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was inserted and removed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the haptic of a pcb00 26.0 diopter intraocular lens (iol) was bent when inserting into the patient's operative eye.Therefore, the lens was removed and replaced with another lens of the same model and diopter.Reportedly, there was no patient injury and the patient is doing fine post-operatively.There was an incision enlargement and suture used, but no vitrectomy was performed.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation.Returned to manufacturer on: 02/06/2019.Device evaluation: the product was returned to the manufacturing site for evaluation.The returned pcb00 device was received in a bag.The plunger was completely in an advanced position and locked.The pcb00 device was observed under microscope and scarce amount of lubricant residues were observed inside the device.Per dfu the viewing window should be filled completely with ovd.The lens was received out of the device cut in two pieces with missing parts and with both haptics detached and missing, most likely due to the removal of the lens from the eye.Based on the sample received the complaint haptic damaged was not verified; the haptic detached condition was observed however it could be related to the scarce amount of viscoelastic observed.No product quality deficiency was identified.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 that no other complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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.
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.; santa ana CA
• MDR Report Key: 8287960
• Report Number: 2648035-2019-00128
• Device Sequence Number: 11378248
• Product Code: HQL
• UDI-Device Identifier: 05050474558380
• UDI-Public: (01)05050474558380(17)210531
• Combination Product (Y/N): Y
• Initial Reporter State: NH
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2020
• 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: 05/31/2021
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 02/12/2019; 10/25/2020
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 03/06/2019; 11/06/2020
• 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