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

Model Number 1MTEC30

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

Lot#: unknown/not provided.Expiration date: unknown as the product lot number was not provided.Unique identifier (udi#): a complete udi number is unknown as the product lot number was not provided.If implanted; give date: n/a (not applicable).The cartridge is not an implantable device.If explanted; give date: n/a (not applicable).The cartridge is not an implantable device; therefore, not explanted.(b)(6).The product is not returning for evaluation as it is discarded; therefore, a failure analysis of the complaint device cannot be completed.The lot/serial number for this device is not available; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.Device manufacture date: unknown, as the lot number of the device was not provided.  all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was initially reported that the cartridge was defective.Additional information was received and it was learnt that there was some deformation at the cartridge tip identified while loading the intraocular lens (iol).The surgeon pushed the lens through the cartridge and this caused damage to the lens.No patient contact was reported.The account commented that the device was discarded and the lot number was not recorded.No further information was 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: PLATINUM 1 SERIES
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8032815
• MDR Text Key: 126081296
• Report Number: 2648035-2018-01426
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 11/02/2018
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZKB00 LENS, SERIAL NUMBER (B)(6)