FDA Adverse Event Injury Summary report: N

SUMMIT APEX PLUS

MDR report key: 243608 · Received September 19, 1999

Report

Report Number
MW4002614
Event Type
Injury
Date Received
September 19, 1999
Date of Event
August 14, 1998
Report Date
September 19, 1999
Manufacturer
SUMMIT TECHNOLOGY, INC.
Product Code
HQF
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

RPTR WRITES: "THE GENERAL SUBJECT IS THE MIRACLES AND SUPPOSED MIRACLES OF MODERN MEDICAL TECHNOLOGY. THE SPECIFIC SUBJECT IS LASIK, LASER ASSISTED IN-SITU KERATOMILEUSIS. I AM A LASIK PT. MY OWN LASIK SURGERY WAS PERFORMED ON BOTH EYES" IN 1998. "I QUERIED ONE OF 'THE DR'S' ASSISTANTS ABOUT WHAT MACHINE WAS USED DURING MY SURGERY. THE ANSWER I REMEMBER RECEIVING IS A 'SUMMIT APEX PLUS.' SINCE THAT TIME, MY LIFE HAS BEEN A NIGHTMARE OF PAIN (IN MY LEFT EYE) & ESOTROPIA (IN MY LEFT EYE). THE ESOTROPIA RESULTS IN DOUBLE VISION, AND THE FOREIGN BODY SENSATION IS AKIN TO A DIRTY CONTACT LENS PERMANENTLY IMPLANTED ON (STUCK TO) THE CORNEA OF MY LEFT EYE. THE ESOTROPIA WAS DIAGNOSED ABOUT 3 MONTHS AFTER THE SURGERY. THE FOREIGN BODY SENSATION IN MY LEFT EYE HAS BEEN A PERMANENT FIXTURE IN MY LIFE SINCE THE TIME OF THE OPERATION. ALSO ACCOMPANYING THESE SYMPTOMS HAS BEEN THE LOSS OF CLEAR EAGLE-EYED NEAR-SIGHTED VISION. THE DR SPOKE A LOT ABOUT PRESBYOPIA DURING PRE-OP CONSULTATIONS. IT APPEARS TO ME THAT LASIK "BURNS AWAY" YOUR NEAR-SIGHTED VISION AND THAT THE SYMPTOMS ARE SIMILAR TO PRESBYOPIA. STRANGE THAT MY OWN PERSONAL SYMPTOMS OF PRESBYOPIA SHOULD EMERGE IMMEDIATELY AFTER THE LASIK PROCEDURE. IN TERMS OF DAY TO DAY LIVING, I WAS SHOCKED TO FIND THAT I COULDN'T READ THE BIG BLOCK LETTERS AT THE OPENING OF THE RECENT PHANTOM MENACE MOVIE, WITHOUT CLOSING ONE EYE. I RECALL SEEING 'RETURN OF THE JEDI' IN 1983 WHEN I WAS WEARING GLASSES, AND HAVING NO SUCH PROBLEMS. THIS IS AN EXAMPLE OF THE DOUBLE VISION AT WORK, AND MY FREQUENT REMEDY - TO CLOSE ONE EYE. WHETHER YOU CALL IT 'LOSS OF EAGLE-EYED NEAR-SIGHTED VISION' OR 'SUDDEN ONSET OF PRESBYOPIA SYMPTOMS IMMEDIATELY FOLLOWING LASIK PROCEDURE', THERE IS ANOTHER EXAMPLE WHICH BRINGS IT HOME REGARDING THE ASPECT OF MY VISION THAT I HAVE LOST. BEFORE THE LASIK I HAD ABOUT 28 YEARS OF METAL-WORKING EXPERIENCE. I COULD LOOK AT AN 0-80 SCREW, THE SIZE YOU MIGHT USE IN A WATCH CASE, AND CLEARLY SEE THE FINE DETAIL OF THE HELICAL THREADS. A SITUATION AROSE AT WORK RECENTLY WHERE I NEEDED TO MAKE A QUICK MODIFICATION ON A PART IN A LATHE. THIS INVOLVES GUIDING THE HEAD OF A CARBIDE TOOL SAFELY TO WITHIN .001 INCH OF A GIVEN DESTINATION. I HAD TO LET SOMEONE ELSE DO THE WORK. WHETHER FOCUSING ON THE THREADS OF A SMALL SHOULDER SCREW OR USING A CARBIDE TOOL TO INCREASE THE LENGTH OF THE SHOULDER, BEFORE THE LASIK OPERATION THESE WERE PLEASURABLE TASKS, INVOLVING THE ABILITY TO FOCUS EFFORTLESSLY ON VERY SMALL OBJECTS. I NO LONGER HAVE THAT ABILITY. I CALL THIS LOSS OF NEAR-SIGHTED VISION, PERMANENT FOREIGN-BODY SENSATION, AND DOUBLE-VISION AN IMPAIRMENT OF VISION. I AM HUNGRY FOR ANSWERS. I HAVE A PERSISTENT FOREIGN BODY SENSATION IN MY LEFT EYE THAT HAS NOT SUBSIDED SINCE THE SURGERY. EVERY TIME I PUT IN EYEDROPS, IT PROVIDES BRIEF, FLEETING RELIEF, AND THEN A RETURN TO THE DUAL CHALLENGE OF BLEPHARITIS AND DRY EYE SYNDROME, WITH WHICH I HAVE BEEN RECENTLY DIAGNOSED BY THE DRS AT MY HMO. THE STRANGE THING IS, BEFORE THE SURGERY, I NEVER USED EYEDROPS, EXCEPT WHEN I WAS EXPERIMENTING WITH CONTACT LENSES. I THINK IT IS SAFE TO SAY THAT I WAS CONTACT LENS INTOLERANT. THEREFORE, I STUCK WITH MY EYEGLASSES. THEN, I MET 'MY DR' AND I GOT THE IMPRESSION THAT I COULD SEE CLEARLY WITHOUT GLASSES, WITH NO IMMEDIATE LOSS IN NEAR-SIGHTED VISION, WITHOUT PAIN, AS SAFELY AS HAVING A CAVITY FILLED AT A DENTIST. IT IS MY UNDERSTANDING OF PRODUCT LIABILITY LAW THAT THERE EXISTS A RULE KNOWN AS THE 'LEARNED INTERMEDIARY RULE,' I.E., THOUGH A MACHINE SUCH AS THE SUMMIT APEX PLUS COULD BE SAID TO HAVE TWO USERS, THE DR AND THE PT, THE MFR OF THE MACHINE IS CONSIDERED BY THE LAW TO HAVE ONE USER - THE DR. IT IS INCUMBENT UPON THE DR TO EXPLAIN THE RISKS ASSOCIATED WITH THE MEDICAL PROCEDURE TO THE PT. IT IS MY SUSPICION THAT THE WORD 'LEARNED' ALSO CARRIES WITH IT THE ESSENCE OF INTEGRITY. PERHAPS YOU CAN HELP ME. DID THE OPERATION PERFORMED BY THE DR USING THE SUMMIT APEX PLUS CAUSE MY OCULAR SURFACE DISEASE TO MANIFEST? IT APPEARS TO ME THAT THE OPERATION HAS HAD THIS EFFECT. ALTHOUGH I HAVE SPENT PERHAPS 3 HRS IN THE DR'S CO OVER TWO YEARS, I CANNOT RECALL ANY TIME WHEN HE HAS ACKNOWLEDGED THAT I HAVE BLEPHARITIS. HOWEVER, AFTER FIVE MINS WITH TWO DIFFERENT HMO OPHTHALMOLOGISTS, I HAVE BEEN TOLD THE SAME THING, 'YOU HAVE BLEPHARITIS.' IS IT POSSIBLE THAT THE SUMMIT APEX PLUS CAUSED MY BLEPHARITIS? DID IT EXIST PRE-OPERATIVELY? IS IT POSSIBLE THAT THE DR NEGLECTED TO DIAGNOSE AND DISCLOSE IT? BASED ON MY CONTACT LENS INTOLERANCE PRIOR TO THE LASIK PROCEDURE, AND THE QUICKNESS OF THE HMO DRS TO DIAGNOSE THIS CONDITION, I CONCLUDE THAT I HAD OCULAR SURFACE DISEASE BEFORE THE PROCEDURE, BUT WAS ASYMPTOMATIC, EXCEPT WHEN I TRIED TO WEAR CONTACT LENSES. THEN I UNDERWENT THE LASIK PROCEDURE, AND THE SYMPTOMS MANIFESTED ASSERTIVELY IN MY LEFT EYE. I AM AFRAID A SIMILAR SCENARIO MAY HAVE OCCURRED RELATIVE TO MY ESOTROPIA. MY MOM, WHO TOOK MY PHOTO-WITH-EYEGLASSES IN 1997, RECENTLY TOOK ONE LOOK AT IT AND SAID, 'YES, YOU'RE A LITTLE CROSS-EYED IN THIS PHOTO.' WHAT DO YOU THINK? DO YOU THINK THE LASIK PROCEDURE CAUSED MY ESOTROPIA TO MANIFEST, OR THAT IT EXISTED PRE-OPERATIVELY? I UNDERSTAND THAT CONVENTIONAL EYEGLASSES CONTAIN A LIMITED PRISM CORRECTION. IS IT POSSIBLE THAT MY ESOTROPIA PRE-EXISTED THE LASIK OPERATION, THAT IT WAS NOT DIAGNOSED AND DISCLOSED, AND THAT THE PRELIMINARY SYMPTOM OF THE ESOTROPIA - DOUBLE-VISION - MANIFESTED ONLY AFTER THE OPERATION, WHEN MY EYES WERE FUNCTIONING WITHOUT THE PROSTHETIC AID OF EYEGLASSES? OF COURSE, BEFORE THE LASIK, MY RIGHT EYE WAS MY DOMINANT EYE. AFTER THE LASIK, MY SLIGHTLY-CROSSED LEFT EYE HAS THE BETTER VISUAL ACUITY. PERHAPS THIS SHIFT OF VISUAL ACUITY AWAY FROM THE DOMINANT EYE IS AN IMPORTANT FACTOR IN MY VISION COMPLICATIONS. IN ANY CASE, I NOTE TWO REFERENCES TO 'STRABISMUS' IN THE FDA LITERATURE. CONTINUED IN B6.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SUMMIT APEX PLUS OPHTHALMIC LASER HQF SUMMIT TECHNOLOGY, INC. * *

Patients

Seq Age Sex Outcome Treatment
1 40 YR Other| R BY SURGEON.| MICROKERATOME - MFR AND MODEL NUMBER UNDISCLOSED