BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16475655 · Received March 2, 2023

    Report

    Report Number
    3012236936-2023-00377
    Event Type
    Injury
    Date Received
    March 2, 2023
    Date of Event
    December 19, 2022
    Report Date
    March 22, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    05050474750739
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: FEB. 28, 2023. SECTION H3. DEVICE EVALUATED MANUFACTURER? YES. DEVICE EVALUATION: THE SUSPECT IOL WAS CUT IN HALF AND WITH AN EDGE CHIP.NO FURTHER ISSUES WERE IDENTIFIED. THE COMPLAINT ISSUES; EXPLANT, BURRY VISION AND SUTURES WERE NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. 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 NO OTHER COMPLAINTS WERE RECEIVED FROM THIS PRODUCTION ORDER. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION.. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW, IT WAS DISCOVERED THAT 1ST SUPPLEMENTAL REPORT SUBMITTED NEEDED CORRECTION ON SOME INFORMATION. THESE ARE THE FOLLOWING: 1. SECTION D9: DEVICE AVAILABILITY SECTION WAS INADVERTENTLY FILLED OUT AS "DEVICE AVAILABLE FOR EVALUATION - YES", ALSO "RETURNED TO MANUFACTURER -BOX, CHECKED", "DATE RETURNED TO MANUFACTURER - FEB. 28, 2023". THIS SECTIONS SHOULD HAVE BEEN LEFT BLANK DURING 1ST SUPPLEMENTAL REPORT SUBMISSION, AS THEY HAVE ALREADY BEEN INDICATED IN THE INITIAL REPORT SUBMITTED. 2. SECTION H6: PRODUCT INVESTIGATION FINDINGS NEEDS TO HAVE CODE 114 (OPERATIONAL PROBLEM IDENTIFIED) ADDED. 3. SECTION H6: INVESTIGATION CONCLUSION CODE SHOULD HAVE BEEN 4315 (CAUSE NOT ESTABLISHED) INSTEAD OF 67 (NO PROBLEM DETECTED). THIS REPORT IS BEING SUBMITTED FOR CORRECTION OF INFORMATION SUBMITTED DURING 1ST SUPPLEMENTAL REPORT SUBMISSION. THE FOLLOWING FIELDS HAVE BEEN UPDATED: SECTION H6: INVESTIGATION FINDINGS: 114. SECTION H6: INVESTIGATION CONCLUSION: 4315. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY PROCEDURE FROM THE PATIENT'S LEFT EYE DUE TO BLURRY VISION. INITIAL OPENING OF THE ORIGINAL TEMPORAL PRIMARY CORNEAL INCISION, SIGNIFICANT INTRAOPERATIVE FLOPPY IRIS SYNDROME WITH IRIS PROLAPSE THAT REQUIRED CLOSING THIS PRIMARY INCISION WITH 10-0 NYLON SUTURES, CREATION OF A SECOND SUPERIOR PRIMARY CORNEAL INCISION WITH SLIGHT ENLARGEMENT FOR LENS EXPLANT WITH SUBSEQUENT 10-0 NYLON SUTURE CLOSURE. IT WAS CONFIRMED IT HAD NOTHING TO DO WITH THE PRODUCT. A VITRECTOMY WAS NOT REQUIRED. ANOTHER JOHNSON & JOHNSON LENS, MODEL ZA9003 22.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. PATIENT OUTCOME REPORTED AS STILL HEALING FROM SURGERY. LAST VISIT, VISUAL ACUITY 20/100 WITH RESIDUAL CORNEAL FOLDS AND ANTERIOR CHAMBER REACTION, PENDING SUTURE REMOVAL AT FOLLOW UP IN 2 WEEKS. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946483 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. DFR00V 05050474750739

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention