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

Model Number Z9002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Blurred Vision (2137); Visual Impairment (2138)

Event Date 09/22/2017

Event Type  Injury  

Manufacturer Narrative

Explant date: if explanted, give date: not applicable, as the lens remains implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a z9002 19.0 diopter lens was implanted in the patient's left eye (os) on (b)(6) 2017.Post-operatively, the patient complained that her vision was very bad, she could not see very well, and experienced blurry vision and nausea.She also commented/thought that she didn't need the lens implants.The outcomes have significantly affected the patient's activities of daily life.There was no patient injury.Reportedly, the patient has seen multiple doctors about the issues and was told that nothing is wrong and it's just dry eyes.Plugs were placed in both of the patient's eyes as intervention by another doctor to address dry eye, which patient stated did not help.The patient was told to use eye drops by the implanting doctor.Patient reported the drops have not helped.No additional information was provided.The patient had bilateral lenses implanted.This report will capture the lens implanted in the patient's left eye.A separate report will be filed for the right eye.

Manufacturer Narrative

The product testing could not be performed as the lens remains implanted.The reported complaint cannot be confirmed.The manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search revealed that no other investigation request has been received for this production order.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS CL
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 7661385
• MDR Text Key: 113153037
• Report Number: 2648035-2018-00941
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474530676
• UDI-Public: (01)05050474530676(17)220203
• Combination Product (y/n): Y
• PMA/PMN Number: P880081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/03/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR