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

Model Number	PCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, best estimate is from (b)(6) 2019 to present.Explant date: if explanted, give date: not applicable, the lens remains implanted in the eye.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search in complaint system revealed that no additional investigation request (ir) has been received for this production order number.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
A male patient who was implanted with an intraocular lens (iol), model pcb00 reported of having an unusual image in his left eye (os).The patient indicated that at night time or sometimes during the day, when he is exposed to light source, such as a traffic light, auto headlight or street light without any glasses, the central image is clear/brightest, but there are also two less bright images which the patient described them as shadows or ghost images slightly above or on the sides of the central image.That in some cases it looks like ''ears'' and in other cases it looks like duplicate but less bright images of the central image.The two ghost images are largest at a distance and merge with the central image as the patient gets closer to the light.The patient noted that his ophthalmologist was unable to explain the unusual images.The patient¿s daughter is an optometrist and gave the patient glasses to wear.Patient indicated that although his vison is good but still even with the glasses he has the issues with the images.The patient saw his surgeon few weeks ago and his doctor did not know what he is talking about.The patient also had cataract surgery in his right eye (od) on (b)(6) 2019 which he reports that eye to be perfect without issues.The patient currently is not on any additional medication.The patient will continue visiting his doctor and will communicate his issues and progress to him.No additional information was provided.
Additional Manufacturer Narrative
Additional information: additional information received from the patient indicated that his left eye was fine, he has normal vison and had has no more issues with that eye.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: 9708644
• Report Number: 2648035-2020-00133
• Device Sequence Number: 19626011
• Product Code: HQL
• UDI-Device Identifier: 05050474558236
• UDI-Public: (01)05050474558236(17)221024
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2020
• 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: 10/24/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000185
• 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: 01/20/2020
• Supplement Date Received by Manufacturer: 06/29/2020; 10/25/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 07/24/2020; 11/03/2020
• 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
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005