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 of date of event is between 1/23/2017 and 2/28/2019.If explanted, give date: not applicable, as lens remains implanted.(b)(4).Device evaluation: the lens remains implanted.Therefore, product testing cannot be performed and the reported issue could not be verified.Manufacturing record review: the manufacturing process was evaluated, and the devices were manufactured within specifications.The units were released within specifications.The search revealed that one (1) additional complaint has been received for this production order number, however the complaint is unrelated to this complaint, and a product deficiency was not identified.Labeling review: the labeling review was completed.The directions for use (dfu) adequately provide instructions, precautions, along with warnings for the proper use and handling of the product.Conclusion: 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.
Event or Problem Description
It was reported that a male patient underwent bilateral implants in 2017, and in (b)(6) 2019 was diagnosed with clouding sac.A model pcb00, 18.0 diopter intraocular lens (iol) was implanted in the left eye.The patient reports that ever since the lenses were implanted, he has experienced visual issues, halos, glare, and starbursts.The same surgeon implanted both right and left lenses two years ago.The patient continued with his follow-ups, and he has been complaining of his visual issues but claims that the doctor did not do anything about them.He stated that the last time he went back to his implanting doctor was around (b)(6) 2019, the patient found out that the doctor has moved to another practice.In (b)(6) 2019, the patient then went to his current doctor and was diagnosed with clouding of the sac.The doctor also mentioned to the patient that he has glaucoma and had micro-bypass glaucoma stents put in both of his eyes.Despite the stents, although his vision is ok, the visual issues still annoy him especially during night driving.The patient also initially reported that he underwent a procedure two weeks later, a surgery with a widened incision, but symptoms have not improved.It was later clarified through the physician¿s office that the widening of the incision was a laser procedure that was performed because of the cloudy sac.Despite this procedure being performed in (b)(6) 2019, still the patient¿s visual issues are annoying him.He went back and forth for his check-up but no improvement on his visual issues is happening.Hence, he does not want his right eye to be touched anymore.Additional information received through follow-up with the doctor's office is the patient also underwent yttrium aluminum garnet (yag) for posterior capsule opacification (pco) on (b)(6) 2019 and another yag on (b)(6) 2019 both, for left eye (os).Patient¿s pre-op best corrected visual acuity (bcva) for both eyes was 20/30 and then post-op bcva was 20/20.No other pertinent information was provided.This mdr report pertains to the left eye (os).A separate report is being submitted for the right eye (od).
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 nr-0148919 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: 8454687
• Report Number: 2648035-2019-00383
• Device Sequence Number: 11567857
• Product Code: HQL
• UDI-Device Identifier: 05050474558229
• UDI-Public: (01)05050474558229(17)190814
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020
• 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: 08/14/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000180
• 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: 02/28/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 11/11/2020
• 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