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

Model Number ZCB00

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Red Eye(s) (2038); Visual Disturbances (2140)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown, information not provided.If explanted, give date: not applicable as lens has not been explanted.(b)(4).Device evaluation: the product testing could not be performed as the product cannot be returned since it remains in the patient's eye.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.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 a zcb00 24.0 diopter lens was implanted into the patient¿s right eye.She can see a small shadow in the lower right corner of her right eye.Her eyes are swollen from the surgery and she is experiencing red, watery, sore eyes with stabbing pain.Her doctor prescribed steroid drops.In addition, she still needs to wear tri-focals.Per the patient, her doctor said there¿s a film developing over the lens.The doctor recommended laser surgery which is scheduled for (b)(6) 2019.Per follow-up with the patient she said that in her opinion there is something wrong with the lens.She constantly sees haze, lights, and rings.The patient explained that she does not have the peripheral vision she used to have before she got the iols implanted.The patient complained of still needing to wear reading glasses.No further information was provided.The left eye will be reported in a separate mdr.

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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9113016
• MDR Text Key: 160912091
• Report Number: 2648035-2019-01035
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531796
• UDI-Public: (01)05050474531796(17)221107
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000240
• 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
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention