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

Model Number 1MTEC30

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

If implanted, give date: not applicable, as the product was not implantable.If explanted, give date: not applicable, as the product was not implantable.It was indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device cannot be completed.A review of the device/lot history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The customer reported that during handling; prior to insertion of the intraocular lens (iol), they noted the cartridge was bad and had ripped the haptic of the lens.Further follow up was provided and confirmed that when the doctor was inserting the lens, a piece of the cartridge had broken and was in the eye.The piece was removed from the eye incision.No patient injury or complications happened as the problem was caught prior to the lens implant.The only intervention was to retrieve a new lens and cartridge, which was placed without complication.No additional information was provided.

Manufacturer Narrative

Device available for evaluation: yes.Returned to manufacturer on: 10/22/2018.Device returned to manufacturer: yes.Device evaluation: the cartridge was not returned in its original trays.Visual inspection using magnification was performed.The cartridge tip was observed.The cartridge tube was observed with a crack defect.The condition of the cartridge returned is consistent with a unit that has been damaged by the contact of the metal rod tip from the hand piece tool during surgical process.The rod tip protrudes through the cartridge tube creating ¿cartridge cracked¿.There was no piece of plastic or foreign object observed in the returned cartridge.The debris in question was not observed in the return.The reported debris issue could not be verified.No product deficiency was identified.Manufacturing records review: during the manufacturing record review of the production order for this serial number, no product deficiency was identified.The documentation shows that the production order was manufactured according to specifications.Historical data analysis: a search of complaints revealed no additional investigation request for this manufacturing lot number cd04402.Labeling review: the labeling review was completed and revealed that the directions for use(dfu) provide the customer with proper usage instructions and guidelines.No labeling changes are required.Conclusion: as a result of the investigation there is no indication of a product malfunction or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Device available for evaluation: yes.Returned to manufacturer on: 10/22/2018.Device returned to manufacturer: yes.Device evaluation: the cartridge was not returned in its original trays.Visual inspection using magnification was performed.The cartridge tip was observed.The cartridge tube was observed with a crack defect.The condition of the cartridge returned is consistent with a unit that has been damaged by the contact of the metal rod tip from the hand piece tool during surgical process.The rod tip protrudes through the cartridge tube creating ¿cartridge cracked¿.There was no piece of plastic or foreign object observed in the returned cartridge.The debris in question was not observed in the return.The reported debris issue could not be verified.No product deficiency was identified.Manufacturing records review: during the manufacturing record review of the production order for this serial number, no product deficiency was identified.The documentation shows that the production order was manufactured according to specifications.Historical data analysis: a search of complaints revealed no additional investigation request for this manufacturing lot number cd04402.Labeling review: the labeling review was completed and revealed that the directions for use(dfu) provide the customer with proper usage instructions and guidelines.No labeling changes are required.Conclusion: as a result of the investigation there is no indication of a product malfunction or 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; santa ana CA
• MDR Report Key: 7887817
• MDR Text Key: 120696621
• Report Number: 2648035-2018-01246
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)190413(10)CD04402
• 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: 01/01/2005,11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2019
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CD04402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• 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: LENS MODEL ZCT150 21.5 SERIAL #: (B)(6)