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 08/05/2019

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.Concomitant medical products: healon endocoat, lot number 027850.Concomitant medical products: healon pro, lot number ue31334.Device evaluation: product evaluation could not be performed since the product was not returned for evaluation.As per action/evaluation description the product not returning.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that revealed that six additional investigation requests were received from this production order.Two of the six were for issues unrelated to this complaint, and there was no quality deficiency determined.The remaining four investigations are still waiting for investigation results.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.

Event Description

During a site visit, an observation was made there was some amount of ''viscous material'' coming out of a 1mtec30 cartridge during deployment of a zcb00 intraocular lens (iol).The viscous material was like a residual precipitate, small amount.There were no patient post-op injuries reported and the lens remains implanted.Unfortunately, no product will be returned.The reporter believes that the ¿white syrup¿ material might have come from the cartridge.Through follow-up it was learned that the debris/foreign matter was inside the eye after deployment, and the surgeon removed the debris using forceps.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 (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: 8951555
• MDR Text Key: 156495554
• Report Number: 2648035-2019-00941
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)191102(10)CD11842
• 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
• Report Date: 01/01/2005,11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2019
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CD11842
• 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
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZCB00, SERIAL NUMBER 5237181807; ZCB00, SERIAL NUMBER (B)(4)