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

Model Number	GCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	02/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.If implanted, give date: (b)(6) 2019 is provided as the reported event date is one day post implant.If explanted, give date: not applicable, remains implanted in the eye.(b)(6).Pma/510k: this report is being filed on an international device; tecnis 1-piece iol, model gcb00 that has a similar device, tecnis 1-piece iol model pcb00 which is distributed in the unites states under pma p980040.Device evaluated by mfr: the intraocular lens (iol) is not returning for evaluation as it remains implanted; 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 & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that there was an spike in intraocular pressure (iop) in the patient¿s right eye one day post implant of a monofocal intraocular lens (iol).The patient was treated with diamox.The event was considered not sight threatening.There was no patient complication or related injury reported.Patient status is reported as recovered.No further information provided.
Additional Manufacturer Narrative
Corrected data: in review, it was noted that method, results and conclusion codes were inadvertently not captured in the initial mdr report.Therefore, they have been included in this supplemental report.The following fields were updated accordingly: (b)(4).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 nr-0148919 and capa-010215.

• 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: 8638660
• Report Number: 2648035-2019-00595
• Device Sequence Number: 19316745
• Product Code: HQL
• UDI-Device Identifier: 05050474620599
• UDI-Public: (01)05050474620599(17)211115
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020
• 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: 11/15/2021
• Device Model Number: GCB00
• Device Catalogue Number: GCB0000195
• 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: 04/24/2019
• Supplement Date Received by Manufacturer: 01/10/2020; 10/25/2020
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 02/04/2020; 11/12/2020
• 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