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

Model Number ZCB00

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Iritis (1940); UGH (Uveitis-Glaucoma-Hyphema) Syndrome (2115); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If implanted; give date: exact date not provided; but noted as about 6 months ago.The serial number of the device was not provided.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned.The customer's reported complaint could not be verified.Manufacturing record review: a manufacturing record review could not be performed as a serial number was not provided.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.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 Description

It was reported that patient was experiencing uveitis-glaucoma-hyphema (ugh) syndrome.The patient had a model zcb00 +23.5 diopter implanted about 6 months ago and has been experiencing persistent iritis.The doctor believed the iritis was due to the lens'' haptics pressing against the ciliary body.The doctor did a b-scan and could see this.The doctor commented he had not seen this before and thought it may be due to her having some sort of odd anatomy.The lens was explanted and replaced with a non-johnson and johnson lens that was placed in the sulcus with optic capture.There was no vitrectomy, no incision enlargement, the doctor decided to use a suture.No additional information provided.

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-010215.

• Brand Name: TECNIS 1-PIECE
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8204611
• MDR Text Key: 131696321
• Report Number: 2648035-2018-01669
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/06/2020

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
• Device Operator: Health Professional
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR