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

Model Number 1MTEC30

Device Problem Contamination (1120)

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

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown / not provided. Sex/gender: unknown / not provided. Date of event: 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. An attempt has been made to obtain missing information; however, no definitive response has been received. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

Event Description

It was reported that the 1 mtec cartridge was used and it transferred some ''material'' onto the intraocular lens (iol). It was described as viscous material which occurred during iol delivery into the patient¿s eye. The doctor had to go behind the optic to do irrigation / aspiration to take off the material from the optic. The lens remains implanted and there was no visual issue post-op. No other information was provided. This report is # 2 of 2 reports.

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: 3/2/2020. Section h3. Device returned to manufacturer? yes. Device evaluation: no physical damage or significant visual flaws were observed. Based on the sample evaluation there is no indication of a product malfunction. However, due to increase in trend on event such as this file, capa#9718 was opened to do further investigation. Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications. There were no issues identified on the purchase order (po) to associate the complaint reported with the lens manufacturing process. A search revealed five additional complaints have been received from this production order. 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.

• 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: 9307979
• Report Number: 2648035-2019-01196
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)200429(10)CE03960
• Combination Product (y/n): Y
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/29/2020
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CE03960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Event Location: No Information
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Treatment(s): IOL UNKNOWN MODEL AND SN.; IOL UNKNOWN MODEL AND SN.