MAUDE Adverse Event Report: JOHNSON & 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 Codes	Corneal Edema (1791); No Code Available (3191)
Date of Event	07/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).If explanted; give date: (n/a) the lens is planned to be explanted, but to date it remains implanted.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (model pcb00 +30.0 diopter) was implanted into the patient's operative eye on (b)(6) 2018.Reportedly, the surgeon believes that the lens is either faulty or mislabeled and therefore will explant the lens.Visual acuity (va) pre-operative: 4/10, va post-operative : myopia -10.No additional information was provided.
Additional Manufacturer Narrative
The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
81}" was selected and the device evaluation was inadvertently not included in the supplemental mdr report.Therefore, the device evaluation information has been captured in this supplemental report.Device evaluation: the product testing could not be performed since no product was returned for evaluation (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing record review was performed and no associated nonconformity reports were found.The product was manufactured and released according to specifications.A search in complaint history revealed that no additional complaint was received for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results 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
Corrected data: in review of the file, it was noted that a patient code for (b)(4) was not captured in the previous supplemental mdr.The following section has been updated accordingly: (b)(4).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 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 & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7822332
• Report Number: 2648035-2018-01158
• Device Sequence Number: 13739040
• Product Code: HQL
• UDI-Device Identifier: 05050474558465
• UDI-Public: (01)05050474558465(17)200913
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/02/2020
• 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: 09/13/2020
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000300
• 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: 07/31/2018
• Supplement Date Received by Manufacturer: 08/31/2018; 11/07/2018; 11/15/2018; 10/25/2020
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 09/29/2018; 11/13/2018; 11/28/2018; 11/02/2020
• 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: Other; Required Intervention
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005