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

Model Number 1MTEC30

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Eject (4010)

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

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

Lot #: unknown, not provided.Expiration date: unknown, as the lot number was not provided.Unique identifier number, a complete udi# is unknown as the lot number was 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.Device manufacture date: unknown, as the lot number was not provided all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a zct150 intraocular lens (iol) was stuck in the cartridge and could not advance.Lens was in the incision and it did touch the eye.The lens was not implanted.No issue with procedure, no injury or surgical intervention required.Surgery was completed, another zct150 19.5 diopter lens was implanted.No additional information provided.

Manufacturer Narrative

Device evaluation: the product is not available, the complaint issue reported could not be verified.Manufacturing records review: manufacturing record review could not be performed since lot number is unknown.Historical data analysis: the complaint occurrences per lot/batch could not be performed since lot number is unknown.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified.Attempts have been made to obtain product and missing information; however, to date, no response has been received.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: UNFOLDER CARTRIDGE
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8725269
• MDR Text Key: 148941417
• Report Number: 2648035-2019-00662
• Device Sequence Number: 1
• Product Code: KYB
• 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: 01/01/2005,11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Was Device Available for Evaluation?: No
• 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: ZCT150 LENS, SN: (B)(4) ; ZCT150 LENS, SN: (B)(4)
• Patient Age: 74 YR