MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. PLATINUM 1 SERIES; SURGICAL ADJUNCTS

Model Number 1MTEC30

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

Sex/gender: unknown/ not provided.Lot #: unknown/not provided.Expiration date: unknown because lot number was not provided.Unknown because lot number was not provided.If implanted, give date: not applicable as the cartridge is not an implantable device.If explanted, give date: not applicable as the cartridge is not an implantable device.Device manufacture date: unknown because lot number was not provided.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a zxr00 intraocular lens (iol) was wasted because as the doctor was inserting the lens into the patient's operative eye, he was not able to engage the lens into position in the cartridge.Reportedly, the lens ejected unexpectedly and touched the eye.There was no incision enlargement, no vitrectomy and no sutures done.They used the back-up lens and the surgery went well.No patient complications or post-op injury.No further information was provided.

Manufacturer Narrative

Device evaluation: sample has not been received at site therefore complaint could not be verified.Manufacturing record review: the manufacturing record evaluation and the complaint history review could not be performed since the suspect product lot number is unknown.Labeling review: the labeling review was completed.The directions for use (dfu) adequately provide instructions, precautions, along with warnings for the proper use and handling of the product.Conclusion: as a result of the investigation with very limited information provided, 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.

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: PLATINUM 1 SERIES
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8338593
• MDR Text Key: 136151630
• Report Number: 2648035-2019-00189
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(10)UNKNOWN
• Combination Product (y/n): Y
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,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: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: UNKNOWN
• 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
• Treatment: ZXR00 INTRAOCULAR LENS, SERIAL NUMBER (B)(4); ZXR00 INTRAOCULAR LENS, SERIAL NUMBER (B)(4)
• Patient Age: 53 YR