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

Model Number	ZCB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Codes	Visual Impairment (2138); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, however, patient reported symptoms as visit (b)(6) 2018.If implanted, give date: unknown, an exact date was not provided; however, reported as implanted (b)(6) 2016.If explanted, give date: not applicable as to date the lens was remains implanted and therefore not explanted.(b)(6).To date the lens remains implanted and it is not returning for evaluation; 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 and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (model zcb00 +26.0 diopter) was implanted in the patient's right eye in 2016, after a normal uncomplicated surgery.The patient returned to the surgeon in (b)(6) 2018, complaining of poor vision and strong noticeable halos in the right eye that have increased over time.Reportedly, the surgeon inspected the lens and noticed two (2) parallel pale grey/white stripes across the visual axis of the lens.He has tried to yag (yttrium aluminum garnet) thinking it was pco (posterior capsular opacification) but this was ineffective and he thinks the stripes are actually integrated in the lens so not pco.As this is the patient's only functional eye, he is reluctant to remove the lens unless absolutely necessary.Further follow up with the surgeon on (b)(6) 2018, reported that the lens is still in the eye.The surgeon indicated he was planning to refer the patient to another anterior chamber specialist for review.No further information was provided.
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 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC; santa ana CA
• MDR Report Key: 7684134
• Report Number: 2648035-2018-00985
• Device Sequence Number: 848077
• Product Code: HQL
• UDI-Device Identifier: 05050474531833
• UDI-Public: (01)05050474531833(17)190923
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2019
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000260
• 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: 06/14/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 07/12/2018
• 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: Other
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005