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

Model Number 1MTEC30

Device Problem Contamination (1120)

Patient Problem No Code Available (3191)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

Lot number: unknown, information not provided.Unique device identifier (udi #): complete udi# is unknown, as lot number was not provided.Expiration date: unknown, as 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; therefore, not explanted.Concomitant medical products: tecnis eyhance intraocular lens, model icb00, sn: unknown; standard technis cartridge injector; non-johnson and johnson machine; non-johnson and johnson viscoelastic.(b)(6).Device manufacture date: unknown as lot number was not provided.(b)(4).Device evaluation: the complaint sample was not returned to the manufacturing site; therefore, product testing could not be performed, and the customer's reported complaint could not be verified.Manufacturing record evaluation: manufacturing record review cannot be performed since the lot number is unknown.A search of complaints related to lot number cannot be performed since the lot number is unknown.Conclusion: no sample was returned, and the lot number is unknown; an investigation could not be performed.A product deficiency could not be determined.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision has been submitted.

Event Description

It was reported that during the post-operative examination, the doctor noticed foreign body in the operative eye of a patient.The foreign body looks like a small sharp chunk of plastic.The cataract surgery was performed on (b)(6) 2019 and the foreign body issue was noticed on (b)(6) 2020.This is the second case which the surgeon has had of retained foreign body following a cataract surgery.The doctor does not know the source of the fragment and suspects the cartridge.It was indicated that the possible options would be the cartridge or the outer edge of the intraocular lens.The doctor noted that a fragment of the phaco sleeve would be unlikely the cause as it appears to be clear, not pink.It was reported that the cartridge was discarded and is not available.There was no incision enlargement, no vitrectomy and no sutures required when the lens was implanted during the initial surgery.A secondary surgical intervention was required to remove the foreign material from the patient eye.No additional information was provided.Additionally, it was noted that the surgeons do not routinely inspect every lens before they are loaded into an injector.They will look at it once it is folded and in the cartridge only, in order to see if the folding has been correctly done.Once in the eye and unfolded the lens is always checked/looked at by the surgeon.It was indicated that the viscoelastic (ovd) and the system used were competitor¿s devices.The doctor noted that the fragments themselves are too large to have travelled down the cannula of the ovd so it unlikely to be the source.The surgeon reported that he did get two (2) foreign bodies/foreign material out which he managed to save one of them.No additional information was provided.The surgeon reported that he has experienced this issue on two patients.This report pertains to the event reported with the second patient.A separate report is being submitted for the event with the first patient.

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: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10182839
• MDR Text Key: 196780840
• Report Number: 2648035-2020-00454
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/29/2020

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?: No
• 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: 05/27/2020
• Initial Date FDA Received: 06/23/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR