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

Model Number 1MTEC30

Device Problems Crack (1135); Split (2537)

Patient Problem No Patient Involvement (2645)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

Lot #: unknown, not provided.Expiration date: unknown as product lot number was not provided.Unique identifier (udi#): unknown as product lot number was not provided.If implanted, give date: not applicable as this is not an implantable device if explanted, give date: not applicable as this is not an implantable device the device was not returned for analysis as to date.The lot number for this device is not available; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed 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

The surgery center reported split cartridge, that the cartridge cracked at the tip.There was no patient contact.No further information provided.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 7/18/2018.Device returned to manufacturer? yes.Device evaluation: the reported unit was received.Visual inspection using magnification was performed.The cartridge tube was observed with a crack defect (shaped hole).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 cracked cartridge (shaped hole).The reported issue was verified on the return.However, there is no evidence to suggest that the complaint sample has been affected by the manufacturing process.No product deficiency was identified.Manufacturing record review: a manufacturing record review could not be performed as no lot number 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.

• 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: 7595760
• MDR Text Key: 110873011
• Report Number: 2648035-2018-00864
• 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
• Report Date: 01/01/2005,09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• 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: 07/18/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LENS MODEL ZKB00, SERIAL NUMBER (B)(4) ; LENS MODEL ZKB00, SERIAL NUMBER (B)(4)