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

Model Number 1MTEC30

Device Problems Difficult or Delayed Positioning (1157); Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

If implanted; give date: n/a (not applicable).The intraocular lens was not implanted.If explanted; give date: n/a (not applicable).The intraocular lens was not implanted.Lot #: unknown, was not provided.Expiration date: unknown, since lot number was not provided.Udi#: unknown since product lot number was not provided.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

Reportedly, the zct450 lens was tight and difficult to inject into the patient's eye as it was stuck in 1mtec30 cartridge.It was only partially implanted with the front haptic into the patient's eye.Insertion was aborted and lens pulled out of the eye.There was no injury to the patient and no other measures were done.No additional information provided.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 8/07/2018.Device returned to manufacturer? yes.Device evaluation: the 1mtec30 cartridge was not returned it its original package.Visual inspection using microscope magnification was performed: residues of lubricant material were observed on cartridge.The cartridge tip section was observed slightly deformed.The lens was also observed damaged and stuck in cartridge.The condition in which the sample returned is consistent with a product that was handled and prepared for a surgical process.The complaint issue reported was verified.Based on the analyzed of the returned, there is no indication of product quality deficiency.Manufacturing record review: a manufacturing record review could not be performed as no lot number was provided.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: as a result of the investigation 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 nr-0148919 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: 7667958
• MDR Text Key: 113391945
• Report Number: 2648035-2018-00956
• 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: K961242
• 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: 01/01/2005,10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2018
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• 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: INTRAOCULAR LENS SERIAL NUMBER (B)(4)