IDESIGN ADVANCED WAVESCAN STUDIO G300Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05050474591912), received between Aug 31, 2016 and Aug 6, 2024 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fire” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS PART OF A STUDY, PATIENT HAD SURGERY FOR MONOVISION TREATMENT. PATIENT CONSISTENTLY COMPLAINED OF BLURRY VISION IN THE LEFT EYE (OS), DIFFICULTY FOCUSING, AND DECREASED VISION, WITH THE COMPLAINTS WORSENING OVER TIME. AFTER EXPERIENCING THESE SYMPTOMS FOR OVER SIX MONTHS, THE PATIENT PREFERRED SURGICAL INTERVENTION. THE SURGEON CHOSE TO PROCEED WITH THE SURGERY USING THE WAVELIGHT LASER, LEADING TO THE PATIENT'S EXIT FROM THE STUDY. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE I DESIGN. A SEPARATE REPORT WILL BE FILED AGAINST THE STAR LASER.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19923776 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LASIK PROCEDURE PERFORMED ON (B)(6) 2023 AND PRESENTED AT ONE DAY POST OP REPORTING THAT EVERYTHING WAS BLURRY AND THERE WAS A LITTLE DRYNESS. PATIENT WAS GIVEN A SAMPLE OF REFRESH DROPS AND WAS TO CONTINUE WITH CURRENT MEDICATIONS. ON (B)(6) 2023 PATIENT WAS SEEN FOR BLURRY VISION IN BOTH EYES. THE TIMING IS DESCRIBED AS SUDDEN ONSET AND QUALITY IS IMPROVING A LITTLE. PATIENT FEELS LIKE HE HAS SLEPT IN CONTACTS. RECOMMENDED READERS +1.50 AND LASIK ENHANCEMENT. RELIFT ENHANCEMENT BOTH EYES WAS PERFORMED ON (B)(6) 2023 AND PATIENT TO CONTINUE WITH MEDICATION. ON (B)(6) 2023, 6 MONTHS POST-OP PATIENT DESCRIBES IT TAKES FEW MINUTES IN THE MORNING TO ADJUST AND READING IS BLURRY. RELIEF IS EXPERIENCED FROM READERS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Dry Eye(s); Visual Impairment

  MAUDE report 19515702 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCOUNT REPORTED PATIENT HAD PHOTOREFRACTIVE KERATECTOMY TREATMENT AND PRESENTED HYPEROPIC POST TREATMENT. PATIENT INITIAL VISIT REFRACTION: RIGHT EYE +1.50-0.75X144 20/20. LEFT EYE +1.75 SPH 20/20. CYCLOPEGIC REFRACTION: RIGHT EYE +1.75-0.75X141. LEFT EYE +1.75 SPH. PRK TREATMENT: RIGHT EYE +1.46-0.79X130 20 MICRONS. LEFT EYE +3.75 (GOAL OF -2.00 FOR NEAR) 36 MICRONS. 3 MONTHS POST OP REFRACTION: RIGHT EYE +1.25--0.75X135 20/20. LEFT EYE -0.50-0.25X136 20/20. 5 MONTHS POST OP REFRACTION: RIGHT EYE +0.25-1.00X180 20/20. LEFT EYE -0.25-0.25X155 20/30.

  Patient problems: Visual Impairment

  MAUDE report 14215331 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LASIK CUTOMVUE MYOPIC TREATMENT ON (B)(6) 2021. PRESENTED 1 DAY POST OP WITH FOREIGN BODY SENSATION AND AT ONE WEEK POST REPORTED HAVING PRESSURE SENSATION LIKE A SLIGHT HEADACHE WITH BLURRY VISION. AT THE 1 MONTH POST OP VISIT PATIENT REPORTED VISION NOT GOOD IN RIGHT EYE AND BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/50. TEARING REPORTED. PATIENT HAD A LID SCRUB PERFORMED. AT 2 MONTH POST-OP ON (B)(6) 2021 PATIENT HAD RE-TREATMENT OF RIGHT EYE. RIGHT EYE -1.75 X 0.75 X 165 BCVA 20/50 (PRIOR TO RE-TREATMENT) RIGHT EYE REPEAT -1.50 X 0.50 X 169 BCVA 20/40 +2. PATIENT REPORTED THAT RIGHT NOT GOOD FOR DISTANCE, HAVE TEARING AND IS BLOODSHOT EXPERIENCE FOREIGN BODY SENSATION. PATIENT CLAIMS THAT WHEN TAKING SHOWERS EYE GETS FOGGY AND LAST 1/2 HOUR AND STILL EXPERIENCING SOME DOUBLE VISION. 9 WEEK POST-OP ON (B)(6) 2021 (3 MONTH POST-OP) RIGHT EYE (OD) -1.00 X 0.75 X 138 SANDS CORRECTED VISUAL ACUITY 20/50 BCVA 20/20. PATIENT REPORTS NEW PAIN, TEARING, NO VISUAL IMPROVEMENT.

  Patient problems: Blurred Vision; Foreign Body Sensation in Eye; Headache; Visual Impairment

  MAUDE report 12734436 ↗
• MalfunctionJul 8, 2021Fire; Fire

  IT WAS REPORTED THAT THE SYSTEM WAS SMOKING AND SMELLED LIKE A ¿USED FIRECRACKER¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12137594 ↗
• InjuryApr 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT WAS PRESENTED WITH CENTRAL ISLAND. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE IDESIGN AWS SYSTEM. A SEPARATE REPORT WILL BE SUBMITTED FOR THE EXCIMER LASER SYSTEM.

  Patient problems: No Code Available

  MAUDE report 9919155 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT HAD SURGERY ON (B)(6) 2017. AT 3 DAY POST OP UNCORRECTED VISUAL ACUITY IN RIGHT EYE WAS 20/50 -1 WITH PINHOLE AT 20/20-1 AND LEFT EYE WAS 20/50-2 WITH PINHOLE AT 20/30 +2. 5 DAY POST OP UNCORRECTED VISUAL ACUITY RIGHT 20/30 -2 AND LEFT 20/25 +2 6 DAY POST OP UNCORRECTED VISUAL ACUITY RIGHT 20/20 AND LEFT 20/25 +-1 REFRACTION RIGHT .75 X -0.50 X005 20/20 -1 LEFT PLANO -.50 X 142 20/25 -1 2+ SUPERFICIAL PUNCTATE KERATITIS BOTH EYES 11 DAY POST OP UNCORRECTED VISUAL ACUITY RIGHT 20/30 AND LEFT 20/30 +-1 REFRACTION RIGHT 2.25 X -0.50 X 180 20/25-2 LEFT 1.75 -.50 X 007 20/25 -2 INFERIOR 1+ SUPERFICIAL PUNCTATE KERATITIS IN BOTH EYES QUICK TAPER ON LOTEMAX 4 TIMES A DAY, FOR 3 DAYS THEN DISCONTINUE AND ARTIFICIAL TEARS EVERY HOUR. 18 DAY POST OP UNCORRECTED VISUAL ACUITY RIGHT 20/30-1 AND LEFT 20/30 -1 WITH HORIZONTAL DIPLOPIA REFRACTION RIGHT 3.50 X -0.50 X 150 20/20 -1 LEFT 1.75 -.50 X 005 20/25 -2 23 DAY POST OP ((B)(6) 2017) UNCORRECTED VISUAL ACUITY RIGHT 20/40 +2 AND LEFT 20/30 -1 REFRACTION RIGHT 3.50 X -0.50 X 150 20/20 -1 LEFT 1.75 -.50 X 005 20/25 -2 STARTED CLAPIKS (CONTACT LENS-ASSISTED, PHARMACOLOGICALLY INDUCED KERA

  Patient problems: Keratitis; Pain; Visual Disturbances

  MAUDE report 7329213 ↗
• InjuryOct 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRESENTED FOR THE 3 MONTH POST OP VISIT ON (B)(6) 2017 WITH MILD HAZE IN BOTH EYES. THE HAZE WAS ABOVE AND BELOW THE VISUAL AXES. AT THE 6 MONTHS POST OP VISIT ON (B)(4) 2017 THE HAZE APPEARED MORE DENSE BUT WAS STILL LOCATED ONLY ABOVE AND BELOW THE VISUAL AXIX AND WAS AGAIN NOT CONSIDERED TO BE VISUALLY SIGNIFICANT AS UNCORRECTED VISUAL ACUITY WAS 20/16 IN RIGHT EYE AND 2016 IN LEFT EYE (20/13 BOTH EYES). AT THAT VISIT, THE SUBJECT WAS TREATED WITH FML EVERY 2 HOURS FOR 2 WEEKS. THE SUBJECT WAS SEEN ON THE (B)(6) AND PLACED ON A 6 WEEK FML TAPER ON THAT LAST VISIT. SUBJECT WAS SCHEDULED FOR (B)(6) 2017 BUT DID NOT ATTEND. THIS REPORT IS FOR THE IDESIGN SYSTEM. A SEPARATE REPORT IS BEING SUBMITTED FOR THE VISX SYSTEM.

  Patient problems: Corneal Clouding/Hazing

  MAUDE report 6947055 ↗
• InjuryMay 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT WAS PRESENTED WITH OVERCORRECTION. A DESCRIPTION FROM THE SURGERY CENTER INDICATED THE PATIENT THAT HAD INITIAL LASER TREATMENT PERFORMED ON (B)(6) 2017. AT A ONE MONTH POST-OPERATIVE EXAM, THE PATIENT HAD SUB-OPTICAL RESULTS THAT WERE OVERCORRECTIONS. ALTHOUGH, THE POINT OF REFRACTIVE STABILITY HAD NOT BEEN REACHED, THE SURGEON MADE A DECISION TO SCHEDULE SECONDARY SURGERY AS THE SURGEON REALIZED IT WOULD NOT STABILIZE. THE SURGERY CENTER REPORTED THAT THERE HAVE BEEN NO OTHER INCIDENTS OF OVERCORRECTIONS AND BELIEVES SINCE IT WAS THE FIRST TIME USING THE IDESIGN EQUIPMENT; THE SURGEON HAD CONSULTED WITH ANOTHER SURGEON WHO RECOMMENDED THE HYPER FOCAL LENGTH AND OPTICAL INFINITY SETTINGS, ALTHOUGH HE WAS NOT COMFORTABLE CHANGING THE SETTINGS AT THE TIME, HE HAD CHANGED THE SETTINGS. THE SURGEON BELIEVES CHANGING THE SETTINGS CAUSED THE OVERCORRECTIONS. THE SURGEON HAS REVERTED BACK TO THE DEFAULT SETTINGS AND HAS NO ISSUES SINCE THEN. IN ADDITION, THE SURGERY CENTER REPORTED 4 PATIENTS EXPERIENCED OVERCORRECTIONS. THIS REPORT IS FOR PATIENT #4.

  Patient problems: No Code Available

  MAUDE report 6535348 ↗
• InjuryMay 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT WAS PRESENTED WITH OVERCORRECTION. A DESCRIPTION FROM THE SURGERY CENTER INDICATED THE PATIENT THAT HAD INITIAL LASER TREATMENT PERFORMED ON (B)(6) 2017. AT A ONE MONTH POST-OPERATIVE EXAM, THE PATIENT HAD SUB-OPTICAL RESULTS THAT WERE OVERCORRECTIONS. ALTHOUGH, THE POINT OF REFRACTIVE STABILITY HAD NOT BEEN REACHED, THE SURGEON MADE A DECISION TO PERFORM SECONDARY SURGERY AS THE SURGEON REALIZED IT WOULD NOT STABILIZE. THE SURGERY CENTER REPORTED THAT THERE HAVE BEEN NO OTHER INCIDENTS OF OVERCORRECTIONS AND BELIEVES SINCE IT WAS THE FIRST TIME USING THE IDESIGN EQUIPMENT; THE SURGEON HAD CONSULTED WITH ANOTHER SURGEON WHO RECOMMENDED THE HYPER FOCAL LENGTH AND OPTICAL INFINITY SETTINGS, ALTHOUGH HE WAS NOT COMFORTABLE CHANGING THE SETTINGS AT THE TIME, HE HAD CHANGED THE SETTINGS. THE SURGEON BELIEVES CHANGING THE SETTINGS CAUSED THE OVERCORRECTIONS. THE SURGEON HAS REVERTED BACK TO THE DEFAULT SETTINGS AND HAS NO ISSUES SINCE THEN. IN ADDITION, THE SURGERY CENTER REPORTED 4 PATIENTS EXPERIENCED OVERCORRECTIONS. THIS REPORT IS FOR PATIENT #3.

  Patient problems: No Code Available

  MAUDE report 6535338 ↗
• InjuryMay 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT WAS PRESENTED WITH OVERCORRECTION. A DESCRIPTION FROM THE SURGERY CENTER INDICATED THE PATIENT THAT HAD INITIAL LASER TREATMENT PERFORMED ON (B)(6) 2017. AT A ONE MONTH POST-OPERATIVE EXAM, THE PATIENT HAD SUB-OPTICAL RESULTS THAT WERE OVERCORRECTIONS. ALTHOUGH, THE POINT OF REFRACTIVE STABILITY HAD NOT BEEN REACHED, THE SURGEON MADE A DECISION TO PERFORM SECONDARY SURGERY AS THE SURGEON REALIZED IT WOULD NOT STABILIZE. THE SURGERY CENTER REPORTED THAT THERE HAVE BEEN NO OTHER INCIDENTS OF OVERCORRECTIONS AND BELIEVES SINCE IT WAS THE FIRST TIME USING THE IDESIGN EQUIPMENT; THE SURGEON HAD CONSULTED WITH ANOTHER SURGEON WHO RECOMMENDED THE HYPER FOCAL LENGTH AND OPTICAL INFINITY SETTINGS, ALTHOUGH HE WAS NOT COMFORTABLE CHANGING THE SETTINGS AT THE TIME, HE HAD CHANGED THE SETTINGS. THE SURGEON BELIEVES CHANGING THE SETTINGS CAUSED THE OVERCORRECTIONS. THE SURGEON HAS REVERTED BACK TO THE DEFAULT SETTINGS AND HAS NO ISSUES SINCE THEN. IN ADDITION, THE SURGERY CENTER REPORTED 4 PATIENTS EXPERIENCED OVERCORRECTIONS. THIS REPORT IS FOR PATIENT #2.

  Patient problems: No Code Available

  MAUDE report 6535307 ↗
• InjuryMay 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT WAS PRESENTED WITH OVERCORRECTION. A DESCRIPTION FROM THE SURGERY CENTER INDICATED THE PATIENT THAT HAD INITIAL LASER TREATMENT PERFORMED ON (B)(6) 2017. AT A ONE MONTH POST-OPERATIVE EXAM, THE PATIENT HAD SUB-OPTICAL RESULTS THAT WERE OVERCORRECTIONS. ALTHOUGH, THE POINT OF REFRACTIVE STABILITY HAD NOT BEEN REACHED, THE SURGEON MADE A DECISION TO PERFORM SECONDARY SURGERY AS THE SURGEON REALIZED IT WOULD NOT STABILIZE. THE SURGERY CENTER REPORTED THAT THERE HAVE BEEN NO OTHER INCIDENTS OF OVERCORRECTIONS AND BELIEVES SINCE IT WAS THE FIRST TIME USING THE IDESIGN EQUIPMENT; THE SURGEON HAD CONSULTED WITH ANOTHER SURGEON WHO RECOMMENDED THE HYPER FOCAL LENGTH AND OPTICAL INFINITY SETTINGS, ALTHOUGH HE WAS NOT COMFORTABLE CHANGING THE SETTINGS AT THE TIME, HE HAD CHANGED THE SETTINGS. THE SURGEON BELIEVES CHANGING THE SETTINGS CAUSED THE OVERCORRECTIONS. THE SURGEON HAS REVERTED BACK TO THE DEFAULT SETTINGS AND HAS NO ISSUES SINCE THEN. IN ADDITION, THE SURGERY CENTER REPORTED 4 PATIENTS EXPERIENCED OVERCORRECTIONS. THIS REPORT IS FOR PATIENT #1.

  Patient problems: No Code Available

  MAUDE report 6535238 ↗
• InjuryApr 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LASIK WITH IDESIGN PROCEDURE AND PRESENTED WITH OVERCORRECTION IN RIGHT EYE POST TREATMENT. PATIENT EXPERIENCED LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) EQUAL TO OR ABOVE 2 LINES. NO INTERVENTION WAS REQUIRED. RIGHT EYE: PRE-OP: -6.86 -0.35 X 41 BCVA 20/20, POST-OP: +1.75 -0.25 X 95 BCVA 20/30.

  Patient problems: Visual Impairment

  MAUDE report 6495673 ↗
• InjuryMar 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT EXPERIENCED UNDERCORRECTION ON THE OPERATIVE EYE. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THE PATIENT HAD REGRESSED TO TWO DIOPTERS. THE SURGERY CENTER INDICATED IT IS LIKELY THE PATIENT WILL REQUIRE AN ENHANCEMENT.

  Patient problems: No Code Available

  MAUDE report 6371118 ↗
• InjuryJan 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD SURGERY ON (B)(6) 2016 AND PRESENTED ON (B)(6) 2016 WITH CLINICALLY SIGNIFICANT CORNEAL HAZE IN BOTH EYES (MORE IN LEFT THAN IN RIGHT SIDE) AND LOSS OF 2 LINES BEST SPECTACLE CORRECTED VISUAL ACUITY IN LEFT EYE. PATIENT WAS PRESCRIBED PREDFORTE 1% FOR BOTH EYES EVERY 2 HOURS AND REFRESH TEARS EVERY 2 HOURS. PATIENT WAS TOLD TO RETURN FOR FOLLOW UP IN 10 DAYS. FOLLOW UP OCCURRED ON (B)(6) 2016 WITH MEDICAL FINDING OF MILD CORNEAL HAZE AND RETICULAR PATTERN OPACIFICATION WITHIN ABLATION ZONE, SOMEWHAT LESS DENSE. PER EXAMINING DOCTOR, RESPONDING WELL TO THE TREATMENT. PATIENT TO CONTINUE PREDFORTE AND UV PROTECTION. PATIENT WAS TOLD TO RETURN FOR FOLLOW UP IN 10 DAYS.

  Patient problems: Corneal Clouding/Hazing; Visual Impairment

  MAUDE report 6258924 ↗
• InjuryJan 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON REPORTED THAT A LASER VISION CORRECTION PATIENT HAD SURGERY AND PRESENTED ON (B)(6) 2016 WITH RECURRENT CORNEAL EROSION WITH SURROUNDING BRAWNY EDEMA IN LEFT EYE. IT WAS REPORTED THAT PATIENT IS BEING FOLLOW UP AND SCHEDULED TO BE SEEN THE NEXT DAY, (B)(6). THE SITE NOTIFIED THAT THE PATIENT DID NOT SHOW FOR THE (B)(6) APPOINTMENT HOWEVER WAS SEEN ON (B)(6) 2017 AND ACCORDING TO THE MEDICAL RECORD THE DOCTOR NOTED ADVERSE EVENT RESOLVED. THE RESOLUTION DATE IS THEREFORE (B)(6) 2017.

  Patient problems: Edema; Erosion

  MAUDE report 6250952 ↗
• InjuryJan 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD PHOTOREFRACTIVE KERATECTOMY IN BOTH EYES 7 MONTHS AGO AND REPORTED THAT HE HAD SEVERAL EPISODES WHERE HE HAS AWOKEN IN THE MORNING WITH THE SENSATION THAT HIS EYELIDS WERE STUCK TO HIS EYES. HE REPORTED THAT THE EXPERIENCE GIVES HIM MILD DISCOMFORT BUT IS SYMPTOM FREE BY MID MORNING. HE PRESENTED BECAUSE HE SAID THAT 48 HOURS AGO HE AWOKE WITH DISCOMFORT AND REDNESS THAT DID NOT IMPROVE AND REQUESTED FURTHER EVALUATION. HE WAS FOUND WITH CORNEAL ULCER IN RIGHT EYE: LIKELY RECURRENT CORNEAL EROSION WITH SECONDARY INFECTION. HE WAS ALSO FOUND TO HAVE A CORNEAL INFILTRATE WITHOUT EPITHELIAL DEFECT AND WAS STARTED ON HOURLY VIGAMOX FOLLOWING AN EVERY 15 MINUTE LOADING DOSE. PATIENT WAS SEEN NEXT DAY AND STATED FEELING SLIGHTLY BETTER THAN YESTERDAY WITH MILD DISCOMFORT, WATERING AND NOT LIGHT SENSITIVE. THE CENTRAL INFILTRATE IS NOTED TO BE SLIGHTLY LARGER DIAMETER, NASALLY THAN YESTERDAY. PATIENT WAS PRESCRIBED VANCOMYCIN EVERY HOUR, DOXYCYCLINE 100MG DAILY, BACITRACIN AT BEDTIME AND MOXIFLOXACIN EVERY HOUR. PATIENT WAS SEEN ON (B)(6) THEN AGAIN ON (B)(6). PATIENT IS GETTING BETTER HOWEVER NOT RESOLVED. SURGEON NOTED IN MEDICAL EXAMINATION ¿BLAND OPACITY; NO EPI DEFECT. NO

  Patient problems: Corneal Ulcer; Discomfort; Unspecified Infection

  MAUDE report 6220534 ↗
• InjuryOct 20, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT HAD PHOTOREFRACTIVE KERATECTOMY SURGERY ON (B)(6) 2015 AND PRESENTED AT THE 6 MONTHS POST TREATMENT VISIT WITH OVERCORRECTION IN RIGHT EYE. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). PATIENT MANIFEST REFRACTION AT THE 6 MONTHS FOLLOW UP VISIT FOR RIGHT EYE WAS 2.25 X 0.75 X 125.

  Patient problems: No Code Available

  MAUDE report 6045926 ↗
• InjuryAug 31, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON REPORTED PATIENT HAD ORIGINAL PROCEDURE ON (B)(6) 2016. PATIENT PROGRAMMED TREATMENT WAS RIGHT -5.75 -0.25 X 005 AND LEFT -5.25 -0.25 X 154. PATIENT POST OP WAS: 1 MONTH: RIGHT 1.00 -0.50 66 UNCORRECTED 20/70 BEST CORRECTED 20/30; LEFT 1.25 -1.25 170 UNCORRECTED 20/70 BEST CORRECTED 20/25. THREE MONTHS: RIGHT 2.50 -0.75 165 UNCORRECTED 20/50 BEST CORRECTED 20/20; LEFT 2.75 -2.75 17 UNCORRECTED 20/40 BEST CORRECTED 20/20. SURGEON DID ENHANCEMENT ON (B)(6) 2016. THE CURRENT PRESCRIPTION IS: RIGHT +1.75 -1.00 X 005; LEFT +0.75 -2.75 X 175. THERE IS NO LOSS OF BEST CORRECTED VISUAL ACUITY.

  Patient problems: No Code Available

  MAUDE report 5919675 ↗
• InjuryAug 31, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON REPORTED PATIENT HAD ORIGINAL PROCEDURE ON (B)(6) 2015. PATIENT POST OP WAS: ONE MONTH: RIGHT 3.25 -0.50 61 UNCORRECTED 20/20; LEFT 3.00 -0.50 14 UNCORRECTED 20/25. THREE MONTHS: RIGHT 3.50 -0.75 95 BEST CORRECTED 20/15; LEFT 3.75 -0.75 120 BEST CORRECTED 20/15. SURGEON DID ENHANCEMENT AT 3 MONTHS. PRESCRIPTION 3 MONTHS POST ENHANCEMENT: RIGHT UNCORRECTED 20/20. LEFT 2.25 -1.50 X 20 UNCORRECTED IS 20/30 AND BEST CORRECTED IS 20/30+.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 5919546 ↗