STAR S4 IR 0030-4864Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 05050474573413), received between Aug 31, 2016 and Feb 4, 2026 — classified as 83 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2026Failure to Sense

  IT WAS REPORTED THAT PATIENT EXPERIENCED DECENTRATION IN HER RIGHT EYE FOLLOWING FEMTOLASIK SURGERY WITH VISX STAR S4 IR EXCIMER LASER. DURING THE PROCEDURE IN THE RIGHT EYE, THE EXCIMER LASER WAS UNABLE TO IDENTIFY THE PUPIL FOR AN EXTENDED PERIOD, REQUIRING MULTIPLE ADJUSTMENTS TO THE HEAD POSITION, LASER INTENSITY, AND ROOM LIGHTING, AS WELL AS REPEATED INSTRUCTIONS TO THE PATIENT TO MAINTAIN PROPER GAZE. THE LASER INTERMITTENTLY LOST PUPIL TRACKING THROUGHOUT THE PROCEDURE, CAUSING REPEATED INTERRUPTIONS. THE PATIENT ALSO EXHIBITED INVOLUNTARY UPWARD EYE MOVEMENT, POSSIBLY DUE TO FATIGUE FROM THE PROLONGED PROCEDURE. DESPITE THESE CHALLENGES, THE PROCEDURE WAS COMPLETED AS PLANNED. THE LEFT EYE PROCEDURE WAS UNEVENTFUL. POSTOPERATIVELY, THE PATIENT¿S RIGHT EYE VISION WAS SIGNIFICANTLY WORSE THAN THE LEFT, WITH NO EFFECTIVE CORRECTIVE OPTIONS AND PERSISTENT GLARE, PARTICULARLY AT NIGHT, WHICH IMPAIRED HER ABILITY TO DRIVE. AT THE (B)(6) MONTH FOLLOW-UP, THERE WAS NO IMPROVEMENT IN THE RIGHT EYE¿S VISION. THE SUSPECTED CAUSE WAS DECENTRATION OF THE ABLATION IN THE RIGHT EYE. NO ADVERSE EVENTS WERE REPORTED FOR THE LEFT EYE, AND NO ADDITIONAL PATIENT HARM WAS DESCRIBED BEYOND THE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Disturbances

  MAUDE report 24258622 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD LASIK PROCEDURE ON (B)(6) 2025 ON BOTH EYES AND A BANDAGE CONTACT LENS WAS PLACED. AT ONE DAY POST-OP PATIENT REPORTED THAT HIS VISION IS STILL SLIGHTLY HAZY BUT IMPROVED FROM SURGERY DAY. HE HAS BEEN COMPLIANT WITH PRED-MOXI IN BOTH EYES. PATIENT IS HEALING WELL TO BOTH EYES. HE HAS SOME EPITHELIAL IRREGULARITY IN BOTH EYES. AT ONE WEEK POST PATIENT REPORTS BLURRED VISION IN THE LEFT EYE AT A DISTANCE AND AT NEAR. HE REPORTS DRYNESS IN BOTH EYES. HE REPORTS COMPLIANCE PRED-MOXI 3 TIMES DAILY IN BOTH EYES. AT ONE MONTH POST OP PATIENT PRESENTS WITH EPITHELIAL INGROWTH IN THE LEFT EYE AND BLURRY VISION. HE CONTINUES TO INSTILL PRED-MOXI ONCE DAILY IN BOTH EYES. ON (B)(6) 2025, PATIENT PRESENTS FOR FLAP LIFT WITH EPITHELIAL INGROWTH REMOVAL, LEFT EYE. AT ONE DAY POST OP FLAP DEBRIDEMENT IN LEFT EYE PATIENTS STATES VISION IS DOING WELL AND ALSO REPORTED PAIN BUT HAD DIMINISHED. ON (B)(6) 2025, PATIENT PRESENTED FOR FOLLOW UP AFTER FLAP DEBRIDEMENT, LEFT EYE. HE STATES THE LEFT EYE HAS NOT IMPROVED. ON (B)(6) 2025, PATIENT PRESENTS FOR LASIK ENHANCEMENT EVALUATION, LEFT EYE. HE REPORTS THE LEFT EYE IS BLURRED AT ALL RANGES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. LEFT

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Abrasion; Corneal Clouding/Hazing; Dry Eye(s); Eye Pain; Visual Impairment

  MAUDE report 23865637 ↗
• MalfunctionDec 9, 2025Unintended System Motion; Unintended System Motion

  THE CUSTOMER REPORTED THAT THEIR BED WAS MOVING. FOLLOWING OUR FIELD SERVICE ENGINEER (FSE) VISIT TO PERFORM REPAIRS, THE CUSTOMER STATED, "EVERYTHING IS FUNCTIONING WELL, NO ISSUES. WE HAVE COMPLETED ONE TREATMENT AFTER THE REPAIR, AND THERE WERE NO PROBLEMS WITH THE BED MOVING. THE BED MOVEMENT DID NOT IMPACT PATIENT OUTCOMES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764196 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MEDICAL DEVICE REPORT (MDR) WAS SUBMITTED REGARDING A PATIENT WHO UNDERWENT LASEK EYE SURGERY IN THE UK IN 2022, USING THE VISX STAR S4 IR EXCIMER LASER SYSTEM. SINCE THE PROCEDURE, THE PATIENT HAS EXPERIENCED ONGOING DRY EYE, CORNEAL NEURALGIA, AND SYMPTOMS INCLUDING CONSTANT PAIN, BURNING, ITCHING, CORNEAL ABRASION, FATIGUE, LIGHT SENSITIVITY, AND MENTAL HEALTH CHALLENGES. THE PATIENT REPORTED USING VARIOUS TREATMENTS, INCLUDING EYE DROPS, OINTMENTS, HEAT MASKS, LID HYGIENE, AND SUPPLEMENTS, OVER THE PAST TWO AND A HALF YEARS WITHOUT RESOLUTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Abrasion; Dry Eye(s); Eye Irritation; Eye Pain; Unspecified Eye / Vision Problem; Visual Disturbances

  MAUDE report 22913649 ↗
• MalfunctionApr 27, 2025Misfire; Misfire

  IT WAS REPORTED THAT THERE WAS AN ERROR MESSAGE "LASER ENERGY DROPOUTS" AND SYSTEM STOPPED WORKING HALFWAY THROUGH A HYPEROPIC TREATMENT AND WEREN'T ABLE TO CONTINUE. THE FLAP HAD TO BE PLACED DOWN FOR CONTINUATION AT A LATER DATE. NO PATIENT INJURY WAS REPORTED. THE PATIENT RETURNED ON (B)(6) 2025 TO COMPLETE AND DID GREAT. FIELD SERVICE ENGINEER (FSE) ALSO CONFIRMED THAT THE SYSTEM WAS MISFIRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916022 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: A RETROSPECTIVE STUDY WAS DONE TO ANALYZE THE VISUAL OUTCOMES OF KAMRA (ACUFOCUS INC) INLAY INSERTION IN A COHORT OF PATIENTS REPORTING SUCCESS OF PROCEDURE, COMPLICATIONS, PATIENT SATISFACTION, AND REFRACTIVE OUTCOMES. A TOTAL OF 35 PATIENTS UNDERWENT KAMRA INLAY INSERTION. THERE WERE 9 PATIENTS WITH A SOLE KAMRA INLAY INSERTION, 15 HAD COMBINED LASER VISION CORRECTION (LVC) AND KAMRA INLAY INSERTION ON THE SAME DAY, AND 11 HAD SEQUENTIAL LVC AND KAMRA INLAY INSERTION. THE INTRALASE FEMTOSECOND LASER (ADVANCED MEDICAL OPTICS INC.), WAS USED TO CREATE A LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK) FLAP WHILE LVC ABLATION WAS PERFORMED WITH THE ISX STAR S4 IR LASER (JOHNSON & JOHNSON VISION) ON PATIENTS WHO UNDERWENT SIMULTANEOUS CONSECUTIVE LVC AND KAMRA INLAY INSERTION. POSTOPERATIVE COMPLICATIONS REPORTED INCLUDE STRIAE (N=1 PATIENT), EPITHELIAL INGROWTH (N=1 PATIENT), AND LATE-ONSET ECTASIA (N=2 PATIENTS). PATIENTS WHO UNDERWENT ENHANCEMENT INCLUDE 8 THAT UNDERWENT LASIK, 1 PHOTOREFRACTIVE KERATECTOMY, AND 2 CROSS-LINKING VIA THE DRESDEN PROTOCOL. THIS REPORT IS AGAINST THE STAR LASER. A SEPARATE REPORT WILL BE FI

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21885734 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITERATURE TITLE: COMPARISON OF OBJECTIVE VISUAL QUALITY BETWEEN SMILE AND FS-LASIK IN MODERATE-TO-HIGH MYOPIA. A PROSPECTIVE STUDY WAS DONE TO COMPARE THE CHANGES IN THE CORNEAL WAVEFRONT ABERRATIONS AND THE OBJECTIVE VISUAL QUALITY RESULTING FROM TWO TYPES OF EYE SURGERY¿SMALL INCISION LENTICULE EXTRACTION (SMILE) AND FEMTOSECOND LASER-ASSISTED IN SITU KERATOMILEUSIS (FS-LASIK)¿IN PATIENTS WITH MODERATE-TO-HIGH MYOPIA. A TOTAL OF 186 EYES OF 96 PATIENTS WITH MODERATE-TO-HIGH MYOPIA UNDERWENT REFRACTIVE SURGERIES, INCLUDING SMILE (N=98 EYES OF 51 PATIENTS) AND FS-LASIK (N=88 EYES OF 45 PATIENTS). IN THE FS-LASIK, THE CORNEA FLAP WAS CREATED USING THE INTRALASE IFS 150 FEMTOSECOND LASER (ABBOTT MEDICAL OPTICS, AMO) AND THE EXCIMER LASER CUTTING WAS PERFORMED WITH AN EXCIMER LASER MACHINE VISX STAR S4 EXCIMER LASER SYSTEM (ADVANCED MEDICAL OPTICS INC.). CORNEAL HIGHER-ORDER ABERRATION PARAMETERS FOR THE FS-LASIK GROUP WERE REPORTED AS FOLLOWS WHICH WERE ASSESSED BY THE AUTHORS AS SIGNIFICANT FROM PREOPERATIVE VALUES: 1. TOTAL HIGHER-ORDER ABERRATION (THOA). PRE-OP: 0.41 ± 0.09 POST-OP DAY 1: 0.81 ± 0.34 2. PISTON PRE-OP: 1.39 ± 0.61 POST-OP DAY 1: 0.58 ± 1.41 3. VERTICAL TREFOIL PRE

  Patient problems: Flashers; Visual Disturbances; Visual Impairment

  MAUDE report 21885664 ↗
• MalfunctionFeb 3, 2025Failure to Calibrate; Misfire; Failure to Calibrate; Misfire

  CUSTOMER REPORTED THAT THEIR EXCIMER LASER SYSTEM WILL NOT BOOT UP. NO PATIENT INVOLVEMENT WAS REPORTED. UPON VISITING THE LOCATION, THE FIELD SERVICE ENGINEER (FSE) NOTICED THAT THE SYSTEM FAILED TO BOOT UP AND EXPERIENCED LASER MISFIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21299047 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PHOTOTHERAPEUTIC KERATECTOMY (PTK) PROCEDURE FOR A PATIENT WITH ZONAL CORNEAL DEGENERATION IN ONE EYE WITH THE EXCIMER LASER SYSTEM, THE POSTOPERATIVE CORNEA SHAPE ANALYSIS REVEALED THE PRESENCE OF A CENTRAL ISLAND. THE SETTINGS USED FOR THIS PARTICULAR CASE WERE AS FOLLOWS: EPITHELIUM: PLANO37, S-0.5D, SUBSTANTIAL: 6.0 MM, TZ0.3, FREQUENCY: 10 HZ. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Impairment

  MAUDE report 20872818 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN USING THE EXCIMER LASER DURING PROCEDURE, CENTRAL ISLANDS OCCURRED IN THE PATIENT'S LEFT AND RIGHT EYE. SECOND SURGERY IS PLANNED TO BE CONDUCTED ON (B)(6) 2025. NO FURTHER INFORMATION WAS PROVIDED. PREOPERATIVE VISUAL ACUITY: R 0.1P(0.9×S-4.00 C-1.00 AX90) L 0.1P(0.9×S-4.00 C-0.75 AX50). POSTOPERATIVE VISUAL ACUITY : R 0.04(0.4×S-9.00 C-1.75 AX120) L 0.03(0.4×S-9.50 C-1.00 AX50).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Impairment

  MAUDE report 20659474 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN USING THE EXCIMER LASER DURING PROCEDURE, CENTRAL ISLANDS OCCURRED IN THE PATIENT'S LEFT AND RIGHT EYE. A SECOND SURGERY IS PLANNED TO BE CONDUCTED ON (B)(6) 2024. NO FURTHER INFORMATION WAS PROVIDED. PREOPERATIVE VISUAL ACUITY: R 0.04 (0.4P X S-5.00 C-3.00 AX115) L 0.2 (0.4 X S-2.25 C-1.75 AX85) . POSTOPERATIVE VISUAL ACUITY: R 0.03 (0.2 X S-4.00 C-3.75 AX105) L 0.05 (0.2 X S-3.25 C-1.25 AX75).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Impairment

  MAUDE report 20657578 ↗
• 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 STAR LASER. A SEPARATE REPORT WILL BE FILED AGAINST THE IDESIGN.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19923669 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CUSTOMER COMPLAINED ABOUT DECENTERED ABLATION AFTER FEMTO-LASIK. AS PER ADDITIONAL INFORMATION RECEIVED, THERE WAS NO ANY PATIENT INJURY, HOWEVER, VISION OF THE PATIENT WAS NOT GOOD. PATIENT NEEDED ENHANCEMENT AS THE VISION (UCDVA) WAS 20/50, CDVA : 6/6+2. PATIENT'S LEFT EYE VISION WAS BLURRED AND IT AFFECTS PATIENT'S DAILY WORK LIKE DRIVING. PATIENT COMPLAINED THAT THE VISION WAS NOT GOOD FOR HER LEFT EYE AND STILL UNDER MONITOR BY THE DOCTOR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Impairment

  MAUDE report 19666918 ↗
• MalfunctionSep 13, 2023Fire; Fire

  IT WAS REPORTED THAT THE MONITOR OF THE LASER WAS SMOKING AND HAD TO BE TURNED OFF. THE CASES FOR THE DAY WERE CANCELLED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17738755 ↗
• MalfunctionJul 12, 2023Unintended System Motion; Unintended System Motion

  CUSTOMER REPORTED THAT THEIR STAR LASER CHAIR MOVED WITHOUT ANY INPUT. THE CHAIR WAS LOCKED AND DOCTOR WAS READY TO TREAT. HE PRESSED THE FOOT PEDAL AFTER THE MACHINE VERIFIED IRIS REGISTRATION, AND IT WOULD ACT LIKE IT WAS GOING TO FIRE, BUT IT WOULD STOP TREATMENT DUE TO LOSING FOCUS/TRACKING BECAUSE THE PATIENT WAS MOVING DOWN FROM THE DESIRED SPOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313272 ↗
• InjuryAug 1, 2022Noise, Audible; Noise, Audible

  ACCOUNT REPORTED SEVERAL LASER VISION CORRECTION PATIENTS PRESENTED WITH DIFFUSE LAMELLAR KERATITIS (DLK) OVER THE LAST FEW WEEKS AT ONE DAY POST OP. THE NUMBER OF EYES AFFECTED IS UNKNOWN. IT WAS PROVIDED THAT THE SURGEON EITHER LIFTED AND RINSED FLAP AND INCREASED STEROID DROPS, OR JUST INCREASED STEROID DROPS. THERE WAS NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE DLK HAS BEEN RESOLVED. THERE WERE SEVERAL ATTEMPTS TO GET INFORMATION REGARDING THE AMOUNT OF PATIENTS INVOLVED HOWEVER, AT THE TIME OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: Keratitis

  MAUDE report 15143047 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LASER VISION CORRECTION PATIENT HAD UNCOMPLICATED SURGERY ON BOTH EYES (OU) ON (B)(6) 2021 AND PRESENTED AT 6 WEEK POST OP VISIT WITH DISCOMFORT AND PHOTOPHOBIA. IT WAS NOTED TO HAVE EARLY FLAP MELT AT PERIPHERY RIGHT EYE MORE THAN IN LEFT EYE. PATIENT WAS STARTED ON DUREZOL 4 TIMES A DAY IN BOTH EYES. SYMPTOMS IMPROVED QUICKLY, BUT HE DEVELOPED AN INTERFACE GRANULARITY INFLAMMATION AT THE AREA OF FLAP THINNING, EXTENDING CENTRALLY IN RIGHT EYE AND TRACE INFLAMMATION INFEROTEMPORAL FLAP EDGE IN LEFT EYE. THERE WAS ALSO EPITHELIAL INGROWTH NOTED AND IT WAS RECOMMENDED REMOVAL. ADDITIONAL MEDICATIONS THAT WERE GIVEN WAS VIGAMOX AND PRED FORTE. VISION REMAINS EXCELLENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Pain; Inflammation; Visual Disturbances

  MAUDE report 12595345 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH EPITHELIAL INGROWTH ONE DAY POST TREATMENT. THROUGH FOLLOW UP IT WAS LEARNED THE EPITHELIAL DEFECT WAS SIZEABLE AND RESULTED IN THE MELT WHICH WAS OUTSIDE VISUAL AXIS AND WAS NOT ADJACENT TO THE EPITHELIAL INGROWTH. A FLAP LIFT WAS PERFORMED TO REMOVE THE EPITHELIAL CELL ON (B)(6) 2021. THE SURGEON STATED PART OF THE PERIPHERAL FLAP HAD MELTED BUT THAT WAS OUTSIDE THE VISUAL AXIS. ON POST-OP DAY 3, THE EPITHELIAL IS FILLING IN THE AREA OF THE FLAP MELT AND THERE IS NO CURRENT INGROWTH. PATIENT IS REPORTEDLY DOING WELL AND WILL CONTINUE TO BE MONITORED. THE UNCORRECTED VISUAL ACUITY (UCVA) IS 20/25.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Injury; Visual Impairment

  MAUDE report 12469021 ↗
• InjuryAug 30, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH CENTRAL ISLAND ON THE RIGHT WHICH WAS DISCOVERED AFTER WEEKLY FOLLOW UP. THIS WAS A MODERATE MYOPIA WITH CYL. PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) 20/15, CURRENT BCVA 20/30 (AS OF (B)(6) 2021).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Impairment

  MAUDE report 12389381 ↗
• MalfunctionJul 27, 2021Filling Problem; Mechanical Problem; Misfire; Filling Problem; Mechanical Problem; Misfire

  IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) /2021 THEIR EXCIMER LASER SYSTEM HAD FOOT PEDAL ISSUES. ON (B)(6) 2021, DURING SERVICE OF THE SYSTEM THE FIELD SERVICE ENGINEER REPORTED THAT THERE WAS ALSO A MISS FIRE ISSUE AND HIGH REFILL. NO PATIENT CONTACT AND/OR INJURY WAS REPORTED BY CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229591 ↗
• InjuryJun 21, 2021Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE EXCIMER LASER WOULD NOT CAPTURE IRIS REGISTRATION (IR) AND THAT THE EYE IMAGE LOOKED OUT OF FOCUS. THE PATIENT FLAPS WERE ALREADY CREATED AND THE PROCEDURE HAD TO BE RESCHEDULED. ON (B)(6) 2021 IT WAS CONFIRMED THAT THE PATIENT CAME BACK FOR SECONDARY SURGICAL PROCEDURE. THE TREATMENT WAS COMPLETED SUCCESSFULLY. PATIENT IS DOING WELL. NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032284 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A SURGEON PERFORMED A BILATERIAL PHOTOREFRACTIVE KERATECTOMY (PRK) ON A MALE PATIENT WITH LOW MYOPE USING THE VISX STAR EXCIMER LASER SYSTEM. THE PATIENT PRESENTED SUPERIOR STROMAL HAZINESS IN BOTH EYES (OU) POST TREATMENT. THE LEFT EYE (OS) WAS WORSE THAN THE RIGHT EYE (OD). THE PATIENT HAD APPEARANCE OF DIFFUSE LAMELLAR KERATITIS (DLK). IT WAS STATED THE PATIENT WAS ASYMPTOMATIC AND THE REST OF THE EXAM WAS UNREMARKABLE. ON (B)(6) 2021 IT WAS CONFIRMED THAT THE PATIENT WAS TREATED WITH INCREASED TOPICAL STEROID DROPS. THE PATIENT HAS RECOVERED AND IS DOING GREAT. VISION IS 20/30 OD AND 20/60 OS.

  Patient problems: Corneal Clouding/Hazing; Keratitis

  MAUDE report 11704418 ↗
• MalfunctionApr 1, 2021Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT WHILE LASER WAS FIRING THE TREATMENT STOP DUE TO FLUENCE ERROR. THIS OCCURRED ON THE PATIENT FIRST EYE (RIGHT). SURGEON DECIDED NOT TO COMPLETE THE REMAINING 25 SECONDS AND IS WAITING TO RE-REFRACT THE PATIENT IN A POST OP VISIT TO DECIDE IF ANYMORE LASER TREATMENT IS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11601718 ↗
• MalfunctionJan 29, 2021Computer System Security Problem; Computer System Security Problem

  CUSTOMER REPORTED THAT THEIR TREATMENT WAS INTERRUPTED WITH 12 SECONDS LEFT IN A PHOTOREFRACTIVE KERATECTOMY (PRK) TREATMENT. THEY WERE UNABLE TO BOOST THE LASER, AND COMPLETE THE TREATMENT. PATIENT WAS OK AND NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11251070 ↗
• InjuryJan 14, 2021Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTED PATIENT OUTCOME WAS OVERCORRECTED POST PHOTOREFRACTIVE KERATECTOMY IN RIGHT EYE (OD), LASIK IN LEFT EYE (OS) FROM PROCEDURE COMPLETED IN (B)(6) 2020. PHOTOREFRACTIVE KERATECTOMY RIGHT EYE WAS PERFORMED YEARS AGO IN ANOTHER FACILITY DUE TO INCOMPLETE FLAP. PER FOLLOW-UP, PATIENT WAS ENHANCED ON 12/10/2020. PATIENT IS DOING GREAT SAME DAY POSTOP, 20/50 PHOTOREFRACTIVE KERATECTOMY (PRK) EYE, 20/20 LASIK EYE.

  Patient problems: Visual Impairment

  MAUDE report 11174972 ↗