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

Model Number 1MTEC30

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

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.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 zct150, 23.5 diopter intraocular lens (iol) using a 1mtec (platinum) cartridge, lot number unknown, was partially implanted in the patient¿s eye as the haptic got stuck in the injector.There was no incision enlargement, vitrectomy or sutures required.Back up lens used with no complications.No other information was provided.

Manufacturer Narrative

Device evaluation: the product testing could not be performed as only the folding carton was received.The product was not returned.The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the device cannot be performed since the cartridge lot number was not provided the search in the complaint history for this production order number cannot be confirmed as there was no lot number provided.Labeling review: a complaint history could not be performed since there is no cartridge lot number provided.Conclusion: as a result of the investigation with limited information, there is no indication of a product quality deficiency and the reported issue could not be verified.

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 AND JOHNSON SURGICAL VISION, INC.; 1700 east st. andrew place; santa ana CA 92705
• MDR Report Key: 8156610
• MDR Text Key: 130159997
• Report Number: 2648035-2018-01616
• 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: 01/01/2005,11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• 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: ZCT150, SERIAL NUMBER (B)(4).
• Patient Age: 75 YR