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

Model Number 1MTEC30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endophthalmitis (1835); Inflammation (1932); Vitrectomy (2643)

Event Date 09/24/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).If implanted, give date: not applicable, as the product is not implantable.If explanted, give date: not applicable, as the product is not implantable.(b)(4).The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that patient had endophthalmitis three (3) days after implanting model zxr00v tecnis multifocal iol (intraocular lens).Cells were also confirmed in the eye and the interior of the eye was washed on (b)(6) 2018.Reportedly, the inflammation was not so bad, so it was to be observed for a while.According to the doctor, the patient was weeding after the operation, which it may have been infected with bacteria at that time.Fibrin was precipitated even after washing the eye on the (b)(6) and they are observing the progress at the hospital.Observation at the hospital was due to postoperative endophthalmitis and it was not diagnosed whether it is still infectious or if tass (toxic anterior segment syndrome) was present.It was reported that the inflammation has ceased, but the turbidity has been progressing to the posterior segment of the eye and the doctor plans to undergo vitreous surgery.Additionally, vitreous surgery was performed and inflammation was reported.It was indicated that iol has not been replaced.Reportedly, there is bleeding from the retina and the patient has not recovered yet.The visual acuity is about 20/100 (0.2) but there is also a mild dementia and there is no plan to replace the lens with a monofocal iol.The doctor will use a monofocal lens when the patient needs another eye operation.No additional information provided.

Manufacturer Narrative

Device available for evaluation? yes, returned to manufacturer on: 10/30/2018, device returned to manufacturer? yes.Device evaluation: twenty-nine 1mtec30 cartridges returned unused and unopened at the manufacturing site for investigation.No damage was observed to all cartridges.Also, no presence of foreign matter was noticed on all samples returned.The complaint issue reported was not verified.Based on the analyzed of the returned, there is no indication of product quality deficiency.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 nr-(b)(4) and capa-(b)(4).

• 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: 8007794
• MDR Text Key: 125094959
• Report Number: 2648035-2018-01393
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)190711(10)CD07597
• Combination Product (y/n): Y
• PMA/PMN Number: K081382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2019
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CD07597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• 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: TECNIS SYMFONY OPTIBLUE, ZXR00V, SN (B)(4) ; TECNIS SYMFONY OPTIBLUE, ZXR00V, SN (B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR