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

Model Number 1MTEC30

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/26/2019

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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that when the lens was being inserted into the patient¿s eye, the 1mtec30 cartridge was defective and a piece of plastic was found behind the optic and had to be removed.No other 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 nr-0148919 and capa-010215.

Manufacturer Narrative

Section d10: device available for evaluation? yes.Returned to manufacturer on: 12/23/2019.Section h3: device returned to manufacturer? yes.Device evaluation: the sample was received at site on (b)(6) 2019.Visual inspection revealed residues of viscoelastic observed at the cartridge tube and tip.The cartridge tip was observed damaged/cracked, confirming the reported issue.The condition of the cartridge returned is consistent with a unit that has been damaged by the contact of the metal rod tip from the hand piece tool during surgical use.No foreign material such as ¿piece of plastic loose¿ was found during sample evaluation.The foreign material in question was not observed on the return.Also, the inside of the cartridge was observed free of foreign contamination.The reported issue as ¿foreign material loose¿ could not be verified.The unit was handled and used.Based on the evidence observed, the cartridge has not been affected by the manufacturing process.No product deficiency was identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search on the catsweb system revealed one additional investigation request (ir) received due to ¿cartridge crack, lens damaged¿ for this lot number.The ir is in process, pending sample investigation.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text : placeholder.

• 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: 9517172
• MDR Text Key: 177979059
• Report Number: 2648035-2019-01376
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)200314(10)CE02741
• 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,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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2020
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CE02741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• 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: 11/27/2019
• Initial Date FDA Received: 12/24/2019
• Supplement Dates Manufacturer Received: 01/10/2020; 10/25/2020
• Supplement Dates FDA Received: 01/23/2020; 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN INTRAOCULAR LENS