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 Type  Injury  

Manufacturer Narrative

Date of event: unknown, information not provided.If implanted, give date: not applicable, as the cartridge is not an implantable device.If explanted, give date: not applicable, as the cartridge is not an implantable device.It was indicated that the cartridge is not being returned for evaluation as it was discarded at the time of the surgery; 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.(b)(4).Device evaluation: product testing could not be performed because the product was not returned as it was discarded.A product quality deficiency could not be confirmed.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search of complaints revealed a total of three (03) other complaints were received under this production order.One (01) is not related to the reported tip issue.The other two (02) are due to reported tip issues and are investigation is on-going.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.

Event Description

It was initially reported there was an issue with 1mtec30 cartridge, lot number ce00078.Through follow up, customer provided additional information confirming reported unfolder issues involved the cartridge tip.After insertion of a zcb00 25.5 diopter intraocular lens (iol), a scratched was observed, the customer stated the scratch was caused by the cartridge.The lens was removed and replaced from the patient¿s eye.There was no serious patient injury, no suture(s), and no vitrectomy.However, an incision enlargement was required.The 1mtec30 cartridge was discarded and the lens was discarded.No additional information provided.

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 nr-(b)(4) and capa-010215.

• 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: 8778788
• MDR Text Key: 150698092
• Report Number: 2648035-2019-00715
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)200103(10)CE00078
• 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: 01/01/2005,11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2020
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CE00078
• 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: ZCB00 IOL SN: (B)(4)
• Patient Outcome(s): Required Intervention