BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTREMEH20 CONTACT LENSES

    MDR report key: 13237067 · Received January 11, 2022

    Report

    Report Number
    MW5106597
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    December 15, 2021
    Report Date
    June 26, 2024
    Manufacturer
    CLERIO VISION
    Product Code
    LPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SOFT CONTACT LENSES FRAGMENT; I'VE WORN CONTACTS FOR OVER 20 YEARS, ALMOST EXCLUSIVELY BAUSH AND LOMB PUREVISION. DURING THAT TIME, I ONLY RECALL A HANDFUL OF LENSES THAT SPLIT OR PIECES BROKE OFF THE EDGES. THOSE WERE EXTENDED-WEAR LENSES, SO IT'S NOT TOO SURPRISING THAT THIS SORT OF THING WOULD OCCUR. IN 2021 I TRIED EXTREMEH2O LENSES. WITH THE FIRST TRIAL PAIR, A CHUNK BROKE OFF ONE LENS. ANOTHER PAIR WAS ORDERED AND THE SAME THING HAPPENED WITH THAT PAIR. I TOLD THE DR. I DIDN'T WANT TO CONTINUE USING THEM, AND HE SAID THE ONLY OTHER OPTION WAS CUSTOM LENSES. I PAID TO SEE A SPECIALIST AND FOUND THAT CUSTOM LENSES WOULD RUN ABOUT (B)(6) EVERY THREE MONTHS. I HAVE NO INSURANCE AND THAT WAS OUT OF THE QUESTION, SO I CONTACTED THE PREVIOUS DR. AND WENT IN FOR ANOTHER EXAM. IT WAS DETERMINED THAT THE ONLY LENSES THAT MIGHT WORK ON MY FLAT CORNEAS WERE THE EXTREMEH20 LENSES, BECAUSE THEY'RE THE ONLY ONES AVAILABLE IN 14.8 DIA. AND 8.7 BC; AND THEY ONLY COME IN DAILY WEAR. I RECEIVED A BOX OF DAILIES FOR EACH EYE AND HAVE WORN A FEW PAIR OVER THE PAST MONTH OR TWO. DURING THAT TIME, A THIRD TO HALF OF THE LENSES HAVE HAD CHUNKS COME OFF THE EDGES. I SAY CHUNKS BECAUSE THEY'RE NOT MINUSCULE FRAGMENTS, THEY ARE GOOD-SIZED CHUNKS. I NEVER FIND THE PIECES IN MY EYES, SO I DON'T KNOW WHERE THEY GO, BUT THE LENSES GO IN WHOLE AND THEN BECOME UNCOMFORTABLE (SOMETIMES WITHIN MINUTES), AND WHEN REMOVED I FIND CHUNKS MISSING. BECAUSE THIS HAPPENED WITH LENSES ORDERED AT DIFFERENT TIMES AND WITH DIFFERENT STYLES, IT APPEARS TO ME THAT WHATEVER MATERIALS THESE LENSES ARE MADE FROM IS INFERIOR AND NOT SUITABLE FOR CONTACTS. NOT EVEN ONES INTENDED TO BE WORN A SINGLE DAY. FDA SAFETY REPORT ID# (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR REPORTER MW5106597 ON 01/25/2022. PT CODE: (B)(6).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR REPORTER MW5106597 ON 04/20/2022.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 5/9/2022 FOR REPORT MW5106597. I ALSO CALLED (B)(6) TO GET FREE REPLACEMENTS FOR A BUNCH OF THE DEFECTIVE LENSES FROM MY ORDER. BESIDES SENDING REPLACEMENTS, THEY ARE ALSO SUBMITTING AN INQUIRY TO THE COMPANY ON BEHALF OF ME, THEIR CUSTOMER. THE REP I SPOKE WITH DIDN'T KNOW IF THERE HAD BEEN OTHER COMPLAINTS ABOUT EXTREME H2O LENSES. THEY ARE GIVING THE CO., MY PHONE NUMBER SO THEY MAY CONTACT ME. THEREFORE I GUESS IT'S OKAY FOR YOU TO PROVIDE IT TO THEM AS WELL. ON (B)(6) I PUT LENSES IN AND WENT SHOPPING. THAT NIGHT AROUND 10 PM I WAS WATCHING TV ON THE COUCH AND SUDDENLY FELT SOMETHING IN MY EYE (DON'T REMEMBER WHICH SIDE). I WENT TO TAKE OUT MY LENSES AND ONE OF THEM HAD A PIECE MISSING FROM THE EDGE AS HAPPENED SO MANY TIMES BEFORE. I WAS ABLE TO REMOVE THE LENS AND THE FRAGMENT SUCCESSFULLY. THEN ON (B)(6) I PUT LENSES IN AND WENT SHOPPING. THAT NIGHT AROUND 10:30 I WAS LYING ON THE COUCH WATCHING TV AND SUDDENLY FELT SOMETHING IN MY RIGHT EYE. I WENT TO TAKE OUT MY LENSES AND THE RIGHT ONE HAD SPLIT IN TWO. I REMOVED HALF THE LENS FROM MY EYE BUT NEVER DID FIND THE OTHER PART - I HOPE IT'S NOT STILL IN THERE. ON (B)(6) 2022 10:52 AM, (B)(6) WROTE: ANOTHER PROBLEM OCCURRED ABOUT 90 MINS AGO. I WAS LYING ON THE COUCH WATCHING TV WHEN IT SUDDENLY FELT LIKE THERE WAS A HAIR OR SOMETHING IN MY LEFT EYE. I WENT INTO THE BATHROOM, WASHED MY HANDS, AND TRIED TO REMOVE THE LENS. ONLY HALF OF IT CAME OUT, THE LENS HAD SPLIT IN TWO. I HAD TO REALLY WORK TO GET THE REMAINING PIECE OUT, AND MY EYE GOT QUITE RED IN THE PROCESS. IN 14 YEARS OF WEARING CONTACTS, I DON'T RECALL THAT HAPPENING WITH ANY OTHER LENS. "I PUT THIS LENS IN YESTERDAY EVENING AND HAD WORN IT FOR ABOUT.." IT'S SO EXASPERATING THAT THESE LENSES KEEP SELF-DESTRUCTING, I CAN'T POSSIBLY BE THE ONLY WEARER THIS HAS HAPPENED TO. AND IT APPEARS THAT I'M NOT. I JUST GOOGLED "EXTREME H20 PROBLEM" AND FOUND A MESSAGE BOARD WITH THE ADDRESS OPTIBOARD.COM. ON ONE PAGE (HTTPS://IS.GD/9VOPGW) SOMEONE POSED THIS QUESTION IN 2005: "ANYONE HAVE EXPERIENCE WITH EXTREME H2O?" ONE OPTOMETRIST ANSWERED, "MOST PEOPLE COMPLAIN THAT THEY TEAR EASY, OR THAT IT'S TOO THICK AND IS NOT AS COMFORTABLE AS ACUVUES." AN OPHTHALMOLOGIST ANSWERED, "ABOUT 2 YEARS AGO THE LENSES WERE TEARING LIKE CRAZY; WE HAD A LOT OF PATIENTS THAT WERE THRILLED WITH THE LENSES BUT ANNOYED WITH THE WASTEAGE (IE: THE LENSES TORE DURING INSERTION OR REMOVAL). ON WEBEYECARE.COM I FOUND THIS BIT OF INFORMATION: "DAILY CONTACTS ARE MADE FROM THIN, DELICATE MATERIALS THAT TEAR EASILY, SO YOU MAY NEED TO HANDLE THEM WITH EXTRA CARE." THAT'S THE FIRST I'VE HEARD ABOUT DAILIES BEING THINNER AND MIGHT EXPLAIN PART OF THE ISSUE; IN THE PAST I'VE WORN EXTENDED-WEAR LENSES BECAUSE I OFTEN SLEEP IN THEM. I WASN'T AWARE THEY ARE MADE THICKER THAN OTHER TYPES. THAT MAY BE WHY I HAD FEW ISSUES WITH DAMAGED LENSES FOR SO LONG. BUT IT DOESN'T EXPLAIN WHY A LENS RIPS IN HALF WHILE I'M MERELY WATCHING TV (AND NOT RUBBING MY EYES). IT ALSO DOESN'T EXPLAIN WHY CHUNKS RANDOMLY BREAK OFF THE OUTER EDGES DURING USE. ON (B)(6) 2022 1:09 PM, (B)(6) WROTE: HERE'S A FOLLOW UP TO MY COMPLAINT. I ORDERED A BOX OF LENSES FOR EACH EYE AND HAVE WORN ABOUT 4-6 PAIR SO FAR. OUT OF THOSE, THREE LENSES HAD CHUNKS COME OUT OF THE EDGE OF THE LENS. THREE DAYS AGO I TOOK MY LENSES OUT IN THE EVENING AFTER I GOT HOME FROM SHOPPING. A SHORT WHILE LATER I FELT SOMETHING IN MY RIGHT EYE AND IT QUICKLY BECAME PAINFUL. I REALIZED IT WAS PROBABLY A PIECE OF LENS AND AFTER A BIT OF RUBBING AND PRODDING I WAS ABLE TO FISH IT OUT WITH MY FINGERS. IT WAS INDEED A PIECE OF LENS, BUT WHEN I CHECKED THE LENS I'D TAKEN OUT EARLIER, IT WAS WHOLE. THAT MEANS THAT PIECE HAD BEEN IN MY EYE SINCE THE NIGHT BEFORE WHEN I REMOVED A LENS WITH A CHUNK MISSING. AS STATED IN MY COMPLAINT, I DO NOT BELIEVE THESE LENSES ARE FIT FOR USE - I THINK THEY ARE HAZARDOUS AND SHOULD BE RECALLED AND DISCONTINUED UNTIL DIFFERENT MATERIAL IS USED TO MANUFACTURE THEM. STILL, I MUST CONTINUE USING THEM SINCE THEY'RE THE ONLY NON-CUSTOM LENSES MADE WITH THESE SPECIFICATIONS. THAT OR "W". OF THE THREE DEFECTS FROM THESE BOXES I SAVED TWO LENSES SO FAR (THE FIRST ONE ACCIDENTALLY GOT DISPOSED OF). AND I SAVED THE PIECE I FISHED OUT OF MY EYE. BUT THEY'RE ALL DRIED OUT AND PROBABLY WON'T BE OF MUCH USE FOR DETERMINING THE CAUSE. I ONLY SAVED THEM BECAUSE THE PLACE I BOUGHT THEM FROM OFFERS FREE REPLACEMENTS FOR DEFECTIVE LENSES AND I KNEW THERE WOULD BE SO MANY THAT THEY MAY NOT BELIEVE ME - THEY MIGHT THINK I'M JUST TRYING TO SCORE FREE LENSES.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 26-JUN-2024, FOR MW5106597. CORRECTING PROCODE INFORMATION. REFERENCE REPORTS: MW5156678, MW5156679, MW5156680, MW5156681, MW5156682, MW5156683, MW5156684, MW5156685.

    Description of Event or Problem · 0

    SOFT CONTACT LENSES FRAGMENT; I'VE WORN CONTACTS FOR OVER 20 YEARS, ALMOST EXCLUSIVELY BAUSH AND LOMB PUREVISION. DURING THAT TIME, I ONLY RECALL A HANDFUL OF LENSES THAT SPLIT OR PIECES BROKE OFF THE EDGES. THOSE WERE EXTENDED-WEAR LENSES, SO IT'S NOT TOO SURPRISING THAT THIS SORT OF THING WOULD OCCUR. IN 2021 I TRIED EXTREMEH2O LENSES. WITH THE FIRST TRIAL PAIR, A CHUNK BROKE OFF ONE LENS. ANOTHER PAIR WAS ORDERED AND THE SAME THING HAPPENED WITH THAT PAIR. I TOLD THE DR. I DIDN'T WANT TO CONTINUE USING THEM, AND HE SAID THE ONLY OTHER OPTION WAS CUSTOM LENSES. I PAID TO SEE A SPECIALIST AND FOUND THAT CUSTOM LENSES WOULD RUN ABOUT (B)(6) EVERY THREE MONTHS. I HAVE NO INSURANCE AND THAT WAS OUT OF THE QUESTION, SO I CONTACTED THE PREVIOUS DR. AND WENT IN FOR ANOTHER EXAM. IT WAS DETERMINED THAT THE ONLY LENSES THAT MIGHT WORK ON MY FLAT CORNEAS WERE THE EXTREMEH20 LENSES, BECAUSE THEY'RE THE ONLY ONES AVAILABLE IN 14.8 DIA. AND 8.7 BC; AND THEY ONLY COME IN DAILY WEAR. I RECEIVED A BOX OF DAILIES FOR EACH EYE AND HAVE WORN A FEW PAIR OVER THE PAST MONTH OR TWO. DURING THAT TIME, A THIRD TO HALF OF THE LENSES HAVE HAD CHUNKS COME OFF THE EDGES. I SAY CHUNKS BECAUSE THEY'RE NOT MINUSCULE FRAGMENTS, THEY ARE GOOD-SIZED CHUNKS. I NEVER FIND THE PIECES IN MY EYES, SO I DON'T KNOW WHERE THEY GO, BUT THE LENSES GO IN WHOLE AND THEN BECOME UNCOMFORTABLE (SOMETIMES WITHIN MINUTES), AND WHEN REMOVED I FIND CHUNKS MISSING. BECAUSE THIS HAPPENED WITH LENSES ORDERED AT DIFFERENT TIMES AND WITH DIFFERENT STYLES, IT APPEARS TO ME THAT WHATEVER MATERIALS THESE LENSES ARE MADE FROM IS INFERIOR AND NOT SUITABLE FOR CONTACTS. NOT EVEN ONES INTENDED TO BE WORN A SINGLE DAY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332608 EXTREMEH2O CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL CLERIO VISION
    1332609 EXTREMEH2O CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL CLERIO VISION DAILY 3283550270
    1332610 EXTREMEH2O CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL CLERIO VISION
    1332611 EXTREMEH2O CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL CLERIO VISION
    1332612 EXTREMEH2O CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL CLERIO VISION DAILY 3283550270
    1332613 EXTREMEH2O CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL CLERIO VISION
    600725 EXTREMEH20 CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL CLERIO VISION
    600726 EXTREMEH20 CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL CLERIO VISION
    600727 EXTREMEH20 CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL CLERIO VISION
    600728 EXTREMEH20 CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL CLERIO VISION
    600729 EXTREMEH20 CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL CLERIO VISION
    600730 EXTREMEH20 CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL CLERIO VISION
    747496 EXTREMEH2O CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL CLERIO VISION
    747497 EXTREMEH2O CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL CLERIO VISION
    968735 EXTREMEH2O CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL CLERIO VISION
    968736 EXTREMEH2O CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL CLERIO VISION
    968737 EXTREMEH2O CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL CLERIO VISION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other| O IRRELEVANT| IRRELEVANT
    1 55 YR Male Other| O IRRELEVANT| IRRELEVANT