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

Model Number 1MTEC30

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2019

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ 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; therefore, not explanted.As noted in the initial report two cartridges were received from the customer as they were unsure which one was involved in the reported event.Therefore, both cartridges will be investigated.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that upon insertion of a zct300 toric intraocular lens (iol)into the patient's eye, the surgeon noticed an opaque wisp or foreign material in the eye.He grabbed it with forceps and removed it from the eye.He described it as hard and sharp as it nicked the patient's iris.The patient is fine and there are no other issues.The surgeon does not think it is a piece of the iol, but thinks it might be a sliver of a cartridge but does not know for sure.There were 2 platinum 1mtec30 cartridges received from the customer as they were unsure which one was involved in the event.No further information was 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 (b)(4) and capa-010215.

Manufacturer Narrative

Section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: 12/30/2019.Section h3: device returned to manufacturer: yes.Device evaluation: as two samples were returned and it is unknown which one was the suspect device, both samples were evaluated.The return samples were received at the manufacturing site that included the packaging components, and cartridge tray.The cartridge was in a plastic bag inside a container.The cartridge was observed with residues of lubricant.Both cartridge tips were in good condition.No particles or foreign material was observed, the reported issue debris/particle could not be verified.Based on the product returned evaluation a product quality deficiency or product malfunction could not be determined.The complaint issue reported 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 no additional investigation requests related to this production order (po)other than the investigations requested for this complaint.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified.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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9351832
• MDR Text Key: 178748608
• Report Number: 2648035-2019-01226
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)200506(10)CE04454
• Combination Product (y/n): Y
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2020
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CE04454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• 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: ZCT300 LENS SERIAL# (B)(4)