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	Intraocular Pressure Increased (1937); Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.Best estimate of date of event is between 10/17/2016 and 3/10/2020.If explanted, give date: not applicable, as lens remains implanted.(b)(4).Device evaluation: the lens remains implanted therefore the complaint issue could not be verified.If the product is received, after the investigation is completed, then the investigation may be re-opened to document the product return evaluation.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional complaints were received from this production order.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 female patient had undergone bilateral intraocular lens (iols) implants in 2016.The patient is currently experiencing intraocular pressure and blurry vision.She claims that she is almost blind in her right eye all the objects look small and very bright.Patient had previous lasik surgery in both eyes and after the procedure, the doctor decided she would be a good candidate to have iols implanted.She would like them to be removed but the doctor informed her that it is not possible.It was learned that initially the patient¿s vision was great, however, a few days later she sees "fiberoptic lights" floating everywhere in both eyes (ou).She feels that it's always too bright.She must wear sunglasses to be able to drive, but cautiously.She would rather drive when it's cloudy, so she won¿t have to wear her sunglasses.The patient reports she has headaches and she went to another doctor who said that her eye pressure was too high.Pressure in the right eye is 40 and the left eye is 60.She was given medications for the pressure and they helped a bit.She kept going back and forth with the surgeon who said that she has iritis.She was given medications which provided help.About 6-7 months after she went back to her doctor who performed the lasik surgery to both eyes, her issue with too much brightness is still there.She has difficulty reading, watching tv, and driving.She needs to wear sunglasses, and these help her move around.Her doctor did not mention to remove the iols, but she's upset that her visual symptoms occurred hence she thought that they may be in a recall.No other information was provided.This mdr report pertains to the left eye (os).A separate report will be 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: 9931529
• Report Number: 2648035-2020-00326
• Device Sequence Number: 2828113
• Product Code: HQL
• UDI-Device Identifier: 05050474558366
• UDI-Public: (01)05050474558366(17)190328
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020
• 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: 03/28/2019
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000250
• 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: 03/10/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 10/30/2020
• 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