BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAYSERT PLUS

    MDR report key: 9882014 · Received March 26, 2020

    Report

    Report Number
    3012304651-2020-00009
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Report Date
    October 13, 2020
    Manufacturer
    RAYNER INTRAOCULAR LENSES LIMITED
    Product Code
    MSS
    PMA / PMN Number
    K141091
    Removal / Correction Number
    RES 85270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE PRODUCT SUBJECT TO THIS REPORT WAS NOT USED. THE LABELLING DISCREPANCY WAS IDENTIFIED DURING PRODUCT PREPARATION AND USE OF THE PRODUCT WAS DISCONTINUED IMMEDIATELY. OUR INVESTIGATION IDENTIFIED THAT AN UNKNOWN NUMBER (MAXIMUM OF (B)(4)) UNITS OF RSP01 INJECTORS FROM LOT V001 HAVE BEEN INTRODUCED INTO THE RAYSERT PLUS RSP01 LOT K030. THE V001 PACKS HAVE UNDERGONE RE-STERILISATION AND THEREFORE THE ACTUAL EXPIRY IS BEYOND 2015; HOWEVER, THIS HAS NOT BEEN TRACKED OR THE PACKAGING UPDATED THEREFORE THE TRUE PRODUCT EXPIRY IS UNKNOWN, TRACEABILITY OF THE RSP BATCH V001 HAS ALSO NOT BEEN MAINTAINED - THERE IS NO REQUIREMENT FOR THIS TO OCCUR WITH BALLAST PRODUCT. STANDARD PRACTICE APPLIED BY MOST PRODUCT USERS IS TO COMPARE/RECONCILE THE OUTSIDE LABEL WITH THE INNER PRODUCT LABEL. IF THIS PRACTICE IS APPLIED, THE USER WOULD IDENTIFY THAT THE PRODUCT WAS EXPIRED PRIOR TO USE AND DISCARD IT. THIS WAS THE MECHANISM BY WHICH THE INCIDENT WAS RAISED TO RAYNER'S ATTENTION. ALTHOUGH CONSIDERED UNLIKELY, A POTENTIAL CONSEQUENCE OF "EXPIRED" PRODUCT BEING USED IS THAT THE PATIENT MAY HAVE A RAPID ONSET INFLAMMATORY RESPONSE (WITHIN 1-2 DAYS) AFTER SURGERY WHICH MIGHT NEED TO BE TREATED WITH STEROIDS (BEYOND THE COURSE OF NORMAL POST-OPERATIVE TREATMENT) AND REQUIRE MONITORING. INFLAMMATION WOULD BE LIMITED/TRANSIENT AND WITH TREATMENT WOULD BE EXPECTED TO RESOLVE IN 5-10 DAYS. IN CONSIDERATION OF THE ABOVE RAYNER INITIATED A VOLUNTARY RECALL. RECALL DOCUMENTATION WAS SENT TO THE FDA ON 17TH MARCH 2020. FDA HAS ASSIGNED THIS ACTION THE REFERENCE RES (B)(4). RAYNER HAS ACHIEVED 75% CUSTOMER RESPONSE RECONCILIATION IN THIS RECALL ACTION. THERE IS A TOTAL OF 5 NON-RESPONDERS WHO DESPITE ALL ATTEMPTS MADE BY RAYNER SURGICAL INC PERSONNEL AND ITS SALES AGENTS HAVE FAILED TO PROVIDE ANY RESPONSE. IT IS NOTED THAT AT THE TIME THE RECALL WAS INITIATED, THE US WAS GOING INTO LOCKDOWN DUE TO COVID-19 AND THAT THE SUSPENSION OF NON-ESSENTIAL SURGERY AND HOSPITAL VISITS BY SALES AGENTS MAY HAVE HAD BEARING ON THE ABILITY TO GAIN RESPONSES TO THIS RECALL ACTION. WHILE THE FIELD SAFETY NOTICE RESPONSE FORMS RECEIVED BY RAYNER INDICATED THAT A TOTAL OF (B)(4) UNITS FROM FIVE DIFFERENT ACCOUNTS WERE AVAILABLE FOR RETURN, 100% INSPECTION OF THE RETURNED PRODUCT BY RAYNER IDENTIFIED THAT 896 UNITS HAD BEEN RETURNED. OF THE (B)(4) UNITS RETURNED, 19 RSP01 K030 PACKS WERE IDENTIFIED TO CONTAIN R-INJ-10 INJECTORS FROM LOT V001 WITH AN EXPIRY OF 17/09/2015. THE OTHER (B)(4) RETURNED UNITS CONTAINED THE CORRECT RSP01 INJECTORS FROM LOT K030 WITH AN EXPIRY OF 2024-01. 36.9% OF THE RSP01 LOT K030 BATCH QUANTITY (TOTAL (B)(4) UNITS) HAVE BEEN RECONCILED. IN CONTRAST TO IOLS, THE IDENTITY OF THE INJECTOR USED TO IMPLANT ANY GIVEN LENS IS RARELY RECORDED THEREFORE MAKING IT UNLIKELY THAT HOSPITALS WILL BE ABLE TO IDENTIFY WHICH IOLS WERE IMPLANTED WITH RSP01 INJECTORS FROM LOT K030. WE HAVE DETERMINED THAT IT IS HIGHLY LIKELY THAT THE REMAINING UNITS OF RSP01 INJECTORS FROM LOT K030 ON THE MARKET IN THE US HAVE BEEN USED AND THAT NO RECORDS OF THEIR USE ARE AVAILABLE. THERE ARE NO ADVERSE EVENTS, INCIDENTS OR INJURIES ASSOCIATED WITH INJECTORS FROM RSP01 LOT K030. IN CONSIDERATION OF THE ABOVE, WE CONSIDER THE US RSP01 RECALL TO BE COMPLETE.

    Description of Event or Problem · 0

    ON 9TH MARCH 2020, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A US HEALTHCARE PROFESSIONAL THAT ON OPENING THE RAYSERT PLUS RSP01 PACK HE IDENTIFIED THAT THE INNER TRAY WAS LABELLED WITH AN EXPIRY OF 2015. THE PRODUCT CARTON IS LABELLED WITH AN EXPIRY OF 2024-01. THE PRODUCT WAS NOT USED, IT WAS RETAINED AND RETURNED TO RAYNER'S US OFFICE. THIS WAS THE INITIATING EVENT FOR RECALL RES 85270 (RAYNER REF. (B)(4) ).

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. THE PRODUCT SUBJECT TO THIS REPORT WAS NOT USED. THE LABELLING DISCREPANCY WAS IDENTIFIED DURING PRODUCT PREPARATION AND USE OF THE PRODUCT WAS DISCONTINUED IMMEDIATELY. OUR INVESTIGATION IDENTIFIED THAT AN UNKNOWN NUMBER (MAXIMUM OF 244) UNITS OF RSP01 INJECTORS FROM LOT V001 HAVE BEEN INTRODUCED INTO THE RAYSERT PLUS RSP01 LOT K030. THE V001 PACKS HAVE UNDERGONE RE-STERILISATION AND THEREFORE THE ACTUAL EXPIRY IS BEYOND 2015; HOWEVER, THIS HAS NOT BEEN TRACKED OR THE PACKAGING UPDATED THEREFORE THE TRUE PRODUCT EXPIRY IS UNKNOWN, TRACEABILITY OF THE RSP BATCH V001 HAS ALSO NOT BEEN MAINTAINED - THERE IS NO REQUIREMENT FOR THIS TO OCCUR WITH BALLAST PRODUCT. STANDARD PRACTICE APPLIED BY MOST PRODUCT USERS IS TO COMPARE/RECONCILE THE OUTSIDE LABEL WITH THE INNER PRODUCT LABEL. IF THIS PRACTICE IS APPLIED, THE USER WOULD IDENTIFY THAT THE PRODUCT WAS EXPIRED PRIOR TO USE AND DISCARD IT. THIS WAS THE MECHANISM BY WHICH THE INCIDENT WAS RAISED TO RAYNER'S ATTENTION. ALTHOUGH CONSIDERED UNLIKELY, A POTENTIAL CONSEQUENCE OF "EXPIRED" PRODUCT BEING USED IS THAT THE PATIENT MAY HAVE A RAPID ONSET INFLAMMATORY RESPONSE (WITHIN 1-2 DAYS) AFTER SURGERY WHICH MIGHT NEED TO BE TREATED WITH STEROIDS (BEYOND THE COURSE OF NORMAL POST-OPERATIVE TREATMENT) AND REQUIRE MONITORING. INFLAMMATION WOULD BE LIMITED/TRANSIENT AND WITH TREATMENT WOULD BE EXPECTED TO RESOLVE IN 5-10 DAYS. IN CONSIDERATION OF THE ABOVE RAYNER INITIATED A VOLUNTARY RECALL. RECALL DOCUMENTATION WAS SENT TO THE FDA ON 17TH MARCH 2020 AND ITS RECALL DOCUMENTATION IS CURRENTLY UNDER REVIEW. FDA HAS ASSIGNED THIS ACTION THE REFERENCE (B)(4). RAYNER IS IN ONGOING COMMUNICATION WITH FDA RECALLS.

    Description of Event or Problem · 1

    ON 9TH MARCH 2020, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A US HEALTHCARE PROFESSIONAL THAT ON OPENING THE RAYSERT PLUS RSP01 PACK HE IDENTIFIED THAT THE INNER TRAY WAS LABELLED WITH AN EXPIRY OF 2015. THE PRODUCT CARTON IS LABELLED WITH AN EXPIRY OF 2024-01. THE PRODUCT WAS NOT USED, IT WAS RETAINED AND RETURNED TO RAYNER'S US OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350635 RAYSERT PLUS RAYSERT PLUS MSS RAYNER INTRAOCULAR LENSES LIMITED RSP01 K030

    Patients

    Seq Age Sex Outcome Treatment
    1