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

Model Number 1MTEC30

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown/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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

The customer reported that the tip of the cartridge split.There was no adverse effect, injury or surgical intervention required.No additional information was provided to johnson and johnson surgical vision, inc.

Manufacturer Narrative

Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search revealed that no other complaint has been received for this production order.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

The complaint device was not investigated at the time the first supplement report was filed on 09/29/2018.The device was received at the manufacturing site on 08/31/2018 where product testing has now been completed.Device available for evaluation? yes.Returned to manufacturer on: 8/31/2018.Device returned to manufacturer? yes.Device evaluation: the cartridge was observed under a microscope with a lens stuck at the end of the cartridge tube.Scarce amount of viscoelastic residue was observed in the tube.The tube was observed cracked and with stress marks.The customer's reported event was confirmed.Directions for use (dfu) state that the use of viscoelastic (fill the entire inside of the cartridge with viscoelastic) is recommended for optimal performance of the cartridge.The product condition could be caused by the scarce amount of viscoelastic used which will cause the lens to become stuck.Extra force will be needed for the hand-piece pushrod to deliver the lens.Based on the visual evaluation of the returned device, it could not be related to the manufacturing process.A product quality deficiency could not be confirmed.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:(b)(4).

• Brand Name: PLATINUM 1 SERIES
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7723781
• MDR Text Key: 115197676
• Report Number: 2648035-2018-01047
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)190308(10)CD02754
• Combination Product (y/n): Y
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,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: 07/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2019
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CD02754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• 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