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

Model Number 1MTEC30

Device Problem Failure to Eject (4010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

Lot #: unknown, not provided.Expiration date: unknown, since the lot number was not provided.Unique identifier (udi#): complete udi# is unknown, since the lot number was not provided.If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an implantable device.Concomitant medical products: aab00 lens, serial number (b)(4); unfolder platinum 1 series, model and lot unknown.Device manufacture date: unknown, since the lot number was not provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during implantation the surgeon could not advance the intraocular lens (iol) through the cartridge.Reportedly, the lens touched the patient's eye.No incision enlargement, no vitrectomy was performed and no sutures were used.Another lens (same model and diopeter size) was implanted as a replacement.The patient was reported doing very well post-op.No further information was provided.

Manufacturer Narrative

Device evaluation: the product testing could not be performed as the product was not returned.The customer's reported complaint cannot be confirmed.Manufacturing record review: manufacturing record review could not be performed since the serial number is unknown.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: based on the investigation results there is no indication of a product quality deficiency.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 (b)(4) 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: 8589738
• MDR Text Key: 144408430
• Report Number: 2648035-2019-00552
• 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: 01/01/2005,11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• 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