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

Model Number 1MTEC30

Device Problems Crack (1135); Positioning Failure (1158)

Patient Problem No Patient Involvement (2645)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

Customer reportedly had difficulty advancing the lens forward and subsequently jammed in the platinum 1 series cartridge model, 1mtec30.Customer attempted again with a different cartridge and it jammed, splitting the cartridge.Another case on the same list of lens had similar issue where it had difficulty moving through the cartridge, so lens had to be loaded again.Through follow-up, the cartridge split back from the tip about 6mm, where the lens comes out without damaged.Reportedly, there was no patient involvement as it occurred prior to insertion into patient's eye.No additional information provided.

Manufacturer Narrative

Device available for evaluation: yes, returned to manufacturer on: 03/20/2019.Device returned to manufacturer: yes.Device evaluation: the device was received at the manufacturing site for evaluation.The cartridge has some viscoelastic at the cartridge tube.Cartridge tip was observed broken.The lens was observed stuck in cartridge.The cause of the failure could not be determined to be on the manufacturing process.The complaint issue cartridge crack and stuck in cartridge was verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specifications.A search in complaints history revealed that one (1) additional complaint issue received for this production order number for the report of stuck in cartridge issue; however, the investigation for that case did not identify any product deficiency.Labeling review: the labeling review was completed and revealed that the directions for use (dfu) provide the customer with proper usage instructions and guidelines.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 (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: 8427509
• MDR Text Key: 139034785
• Report Number: 2648035-2019-00352
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)190927(10)CD10606
• 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,Followup
• Report Date: 01/01/2005,11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2019
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CD10606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• 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: PLATINUM INSERTER SN (B)(4).; PLATINUM INSERTER SN (B)(4).