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	02/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, remains implanted in the eye.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that post implant of the intraocular lens into the patient¿s left eye, intraocular pressure (iop) spiked at the 1-day post-op visit.Reportedly there was patient complication and/or related injury, iop spike requiring treatment was not sight threatening.The lens currently remains implanted in the patient¿s left eye.The patient is taking diamox to reduce the iop.Surgeon uses a wound assisted technique for implantation but during implantation the iol popped from wound and was assisted in to the anterior chamber (ac) during insertion.There was no patient complication and/or related injury.Patient has recovered.No further information provided.
Additional Manufacturer Narrative
Corrected data: the model number (zcb00) was entered inadvertently entered in the initial emdr report which is incorrect.The correct device model is ''gcb00'' which has being corrected in this supplemental mdr report.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 evaluation: the clinical investigation will be covered under the clinical study for this device.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-(b)(4) 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: 8542087
• Report Number: 2648035-2019-00484
• Device Sequence Number: 11198513
• Product Code: HQL
• UDI-Device Identifier: 05050474620605
• UDI-Public: (01)05050474620605(17)211114
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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: 11/14/2021
• Device Model Number: GCB00
• Device Catalogue Number: GCB0000200
• 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: 03/27/2019
• Supplement Date Received by Manufacturer: 01/10/2020; 10/25/2020
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 02/01/2020; 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
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005