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

Model Number 1MTEC30

Device Problem Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

Additional information: lot #: unknown as information was not provided.Expiration date: unknown as product lot number was not provided.Udi #: a complete udi # is unknown as product serial number was not provided.If implanted, if explanted, give date: not applicable, as the cartridge is not an implantable device.Device manufacture date: unknown, as product lot number was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

When inserting 1mtec30 cartridge into the patient¿s operative eye account reported the cartridge broke, end of cartridge was missing, and zct400 16.0 diopter intraocular lens (iol) was crushed into two (02) pieces.It was also reported the doctor used one (01) suture on the primary incision, as resure sealant was used but it did not work, and patient outcome was reported as good.No additional information was provided to johnson & johnson surgical vision.

Manufacturer Narrative

Additional information: device available for evaluation, returned to manufacturer on: 10/16/2019.Device evaluation: the cartridge was observed under microscope (10x) and a scarce amount of viscoelastic residue was observed in the cartridge tube.The cartridge tube and tip were observed broken.This is typically due to a handpiece that was forced during the lens delivery process and due to the scarce amount of viscoelastic used.The lens came out the side of the cartridge.The reported deformed tip was verified in the cartridge returned, but it could not be related to the manufacturing process.It could be related to the handling process as a result of the scarce amount of viscoelastic observed.This could cause a hard delivery of the lens and require extra force on the pushrod making the lens come out the side.No product quality deficiency was identified.Manufacturing records review: the manufacturing records could not be reviewed since the cartridge lot number is unknown.Historical data analysis: the complaint history was not reviewed since the cartridge lot number is unknown.Conclusion: as a result of the investigation, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.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 & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9212911
• MDR Text Key: 163307400
• Report Number: 2648035-2019-01119
• 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: 01/01/2005,11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 10/31/2019; 10/25/2020
• Supplement Dates FDA Received: 11/08/2019; 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IOL ZCT400U160, WITH SERIAL NUMBER (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR