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 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: 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.  (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that after implanting the intraocular lens (iol), foreign substance was on the iol.Extra time was needed to remove the sticky substance on the iol the substance pattern could be silk-like.Doctor checked iol under microscope and it was clear, thinks problem is not caused by iol.Although the silk-like substance can be removed, the doctor thinks that it is not normal.Additional information states the lens is implanted and there are no injuries.No further information is 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; returned to manufacturer on: 1/14/2020 section h3.Device returned to manufacturer? yes.Device evaluation: the returned sample was received in a plastic bag at the manufacturing site for evaluation.Visual inspection at microscope magnification was performed: lubricant material residues can be observed in the cartridge, but no damaged /defect was observed.As per initial report the foreign material was removed, but it was not was not returned for evaluation.Based in the visual inspection performed the reported issue could not be verified and product quality deficiency could not be determined.Manufacturing records review: the manufacturing process record was evaluated and the devices were manufactured within specifications.There was no discrepancy found during the mrr (manufacturing record review).The units were released according to specification with the product intended use as required.A search in complaint system revealed that no additional complaints were received from this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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: 9555980
• MDR Text Key: 179788853
• Report Number: 2648035-2020-00016
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)200530(10)CE05123
• 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,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: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2020
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CE05123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• 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: AAB00 LENS SN: (B)(6)