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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	02/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted; give date: not applicable, the lens remains implanted.(b)(4).It was indicated that the device is not returning for evaluation as it remains implanted; therefore a failure analysis of the complaint device cannot be completed.A review of 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.
Event or Problem Description
The patient called to report her experience with the intraocular lens (iol)implanted in her left eye.Patient reports having bilateral lens implants (b)(6) 2017.Over the past weekend she started having some issues with the lens in her left eye.She is experiencing streaks of light in the left eye, she can see the edge of the lens, has light flashes, and big spots of black floaters when she looks left and right and sees the lens moving.It is also cloudy.After the lenses were implanted she was in her doctor's office every other week.She had enhancements as she was having all kinds of issues.She had the enhancements in (b)(6) 2018, and then another enhancement october 2018.She also stated she is scheduled for a yag (b)(6) 2019.As the consumer was in nevada vacationing, she contacted and made an appointment with a local ophthalmologist.The doctor did a full exam including dilating her eyes and lots of tests.The doctor told her to watch for any signs, like a vail, floaters, or an explosion of white bright light.It could be a detached retina.If she has any significant issues she needs to call him again.She does have a follow up appointment, (b)(6) 2018.Right now it is still her left eye that is blurry and she feels like the lens is moving.Doctor did not state that her symptoms were related to a lens issue; but he did not really say or give her much information.The doctor did share that she could have the lens(es) explanted at a later date.Patient will be seeing the local ophthalmologist again and stated she would provide her diagnosis and any treatments that doctor has advised.
Additional Manufacturer Narrative
Date received by manufacturer was inadvertently reported as 02/19/2018, however the correct date is 2/19/2019.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(b)(4).

• Brand Name: TECNIS 1-PIECE
• 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: 8427487
• Report Number: 2648035-2019-00348
• Device Sequence Number: 16192520
• Product Code: HQL
• UDI-Device Identifier: 05050474531819
• UDI-Public: (01)05050474531819(17)210729
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 07/29/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000250
• 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: 02/19/2018
• Supplement Date Received by Manufacturer: 04/03/2019; 10/25/2020
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 04/03/2019; 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: Other
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005