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FS LASER SYSTEM 20005DRecalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · FS LASER SYS M2, IEK CAP, 120V, 60HZ · Class 1

Quick summary

This Johnson & Johnson FS Laser System, used in eye surgery, appears in 882 adverse event reports, with 869 injuries and no deaths. Many describe eye inflammation (keratitis), blurred vision and vision loss after surgery, with some mentioning flap tears and gas breaking through the cut. A few report flames, sparks or smoke from the laser. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
883
Deaths reported
0
Injuries reported
869
Recalls naming it
0

Summary

The FDA's MAUDE database contains 883 adverse event reports that list this exact device (DI 05050474573451), received between Aug 22, 2016 and Sep 24, 2026 — classified as 869 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (15 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 2 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem846
  • Device Operates Differently Than Expected15
  • Mechanical Problem5
  • Device Displays Incorrect Message3
  • Suction Problem3
  • Computer System Security Problem2
  • Failure to Cut2
  • Fire2

Patient problems

  • No Code Available410
  • Keratitis325
  • Blurred Vision284
  • Visual Impairment133
  • Pain75
  • Dry Eye(s)67
  • Foreign Body Sensation in Eye59
  • Irritation47

Recent adverse event reports

The 25 most recent of 883 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 24, 2026Decrease in Suction

    It was reported by the customer that the patient interface (PI) had Suction loss during the raster pattern, and the stromal bed showed a divet after the lift. There was no patient injury or surgical intervention reported. No further information was provided.NOTE: This report is against the FS Laser. A separate report will be filed against the Patient Interface.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50884132 ↗
  • InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT PATIENT HAD A FLAP TEAR ON UNKNOWN EYE. DOCTOR EXPLAINED THAT WHILE LIFTING THE FLAP, HE NOTICED THE TISSUE APPEARED SLIGHTLY THIN. AS HE CONTINUED, HE OBSERVED A TEAR TOWARD THE HINGE. HE PROCEEDED TO LIFT THE FLAP FULLY AND COMPLETE THE EXCIMER TREATMENT. A BANDAGE CONTACT LENS (BCL) WAS PLACED OVERNIGHT. PATIENT'S VISUAL ACUITY IS 20/80 IN THE AFFECTED EYE, AND EPITHELIAL HEALING IS STILL IN PROGRESS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Eye Injury

    MAUDE report 24328983 ↗
  • InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT PATIENT PRESENTED WITH LOOSE EPITHELIUM AND BANDAGE CONTACT LENS (BCL) WAS PLACED ON BOTH EYES. PRE-OPERATIVELY AND INTRAOPERATIVE THE DOCTOR USES THE FOLLOWING MEDICATIONS; VIGAMOX, NAPHCON-A, ACULAR, PROPARACAINE MIXED WITH SODIUM HYDROXIDE SOLUTION AND BETADINE PREOPERATIVELY. INTRAOPERATIVELY, DOCTOR USES PROPARACAINE MIXED WITH 15 DROPS OF SODIUM HYDROXIDE SOLUTION MANUFACTURED BY FISHER CHEMICAL AS THE TOPICAL ANESTHETIC. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Eye Injury

    MAUDE report 24211228 ↗
  • InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT FROM CASE DAY ON (B)(6) 2025 PRESENTED WITH DIFFUSE LAMELLAR KERATITIS (DLK) BOTH EYES (OU) ON DAY 1 POST OP. PATIENT VISION WAS 20/200 OU. SURGEON STARTED PATIENT WITH STEROID DROP EVERY 2 HOURS FOR 24 HOURS AND THEN STARTED ON ORAL STEROID FOR A 14 DAY TAPER DOSE. SURGEON SAW PATIENT ON (B)(6) 2025 AND LEFT EYE (OS) INFLAMMATION APPEARED TO RESOLVE BUT RIGHT EYE (OD) STILL PRESENTED WITH MILD INFLAMMATION AND WAS CONTINUING WITH STEROID DROPS EVERY 4 HOURS. ON (B)(6) 2025 VISIT OS VISION WAS 20/20 AND OD WAS 20/40. SURGEON WILL SEE PATIENT IN TWO WEEKS AND WILL PROVIDE UPDATE IF FURTHER TREATMENT IS NEEDED. LASER ENERGY SETTINGS WERE DISCUSSED WITH SURGEON AND SURGEON STATED THAT SHE DOESN'T FEEL IT IS LASER INVOLVEMENT BUT FEELS THAT IT IS PATIENT SPECIFIC AS HE HAD OTHER HEALTH RELATED ISSUES AROUND THE SAME TIME, HE HAD THE LASIK PROCEDURE. ADDITIONAL INFORMATION RECEIVED: PRE LASIK-VISUAL ACUITY (VA): SANS CORRECTED; OD 20/350, OS 20/300, OU 20/300, WITH CORRECTION DVO¿S; OD 20/20 OS 20/20-1 OU 20/20. POST LASIK VA 1 DAY; OD 20/60, OS 20/25-1, OU 20/20, 2 DAY; OD 20/250, OS 20/25+2, STARTED ON ORAL PRED, 3 DAY; OD 20/60-2, OS 20/20, 5 DAY; OD 20

    Patient problems: Keratitis

    MAUDE report 21565568 ↗
  • MalfunctionFeb 5, 2025Fire; Fire

    CUSTOMER REPORTED FLAMES AND SPARKS COMING FROM LASER. SYSTEM HAS BEEN SHUT DOWN AND POWER HAS BEEN SECURED AT THE SOURCE AND REQUESTED A SYSTEM CHECK. NO PATIENT INVOLVEMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21314660 ↗
  • InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CUSTOMER ENCOUNTERED A VERTICAL GAS BREAKTHROUGH (VGB) ON THE SECOND EYE OCULUS SINISTER OS (LEFT EYE) IN THE FINAL 5 SECONDS OF THE FEMTOSECOND LASER FLAP PROCEDURE. CONSEQUENTLY, THE SURGEON WAS UNABLE TO FULLY LIFT THE FLAP AND DID NOT PROCEED WITH THE EXCIMER TREATMENT ON THE LEFT EYE. A BANDAGE CONTACT LENS WAS APPLIED TO THE LEFT EYE FOR ONE DAY, AND THE SURGEON PLANS TO PERFORM A SURFACE ABLATION AT A LATER DATE TO COMPLETE THE EXCIMER TREATMENT. THE TREATMENT ON THE OCULUS DEXTER OD (RIGHT EYE) WAS COMPLETED AS EXPECTED. ON 1 DAY POST-OP, CUSTOMER REPORTED THAT THE PATIENT IS DOING WELL IN BOTH EYES, WITH THE TREATED RIGHT EYE ACHIEVING 20/15 VISION AND THE LEFT EYE MAINTAINING ITS BEST CORRECTED VISUAL ACUITY WITHOUT ANY LOSS OF LINES.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Injury; No Clinical Signs, Symptoms or Conditions

    MAUDE report 21314186 ↗
  • MalfunctionJan 12, 2023Fire; Fire

    DURING SERVICE VISIT, FIELD SERVICE ENGINEER (FSE) STARTED TO BOOTUP THE COMPUTER AND DURING PROGRAM SYSTEM STOPPED DUE TO OSCILLATOR TEMP BEING OUT OF SPEC. FSE NOTICED SMELL COMING FROM THE DELIVERY SYSTEM. FSE REMOVED THE COVERS OFF DELIVERY SYSTEM AND RESTARTED LASER SYSTEM AND THEN COULD NOTICE SLIGHT BIT OF SMOKE FROM THE UPPER RIGHT SIDE OF THE GANTRY BOARD. THE SYSTEM WAS TURNED OFF AND THE COVERS WERE PUT BACK ON.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16143403 ↗
  • InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE ACCOUNT REPORTED THAT ONE PATIENT WITH UNKNOWN EYE, HAD VERTICAL GAS BREAKTHROUGH TOWARDS THE END OF THE SURGERY DAY OUT OF 20 EYES AT 90 UM FLAP THICKNESS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Eye Injury

    MAUDE report 14220146 ↗
  • InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE ACCOUNT REPORTED THAT ONE (1) PATIENT ON UNKNOWN EYE, HAD VERTICAL GAS BREAKTHROUGH TOWARDS THE BEGINNING OF THE SURGERY DAY OUT OF 20 EYES AT 90 UM FLAP THICKNESS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Eye Injury

    MAUDE report 14220089 ↗
  • MalfunctionNov 4, 2021Computer System Security Problem; Human-Device Interface Problem; Computer System Security Problem; Human-Device Interface Problem

    IT WAS REPORTED THAT A SOFTWARE ISSUE OCCURRED DURING THE TREATMENT. THE PROCEDURE WAS CANCELLED AND TREATMENT NOT COMPLETED ON THAT SAME VISIT. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12755106 ↗
  • InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT PATIENT HAD A VERTICAL GAS BREAKTHROUGH. DOCTOR DECIDED TO ABORT THE TREATMENT. NO PATIENT INJURY AND/OR COMPLICATIONS WERE REPORTED.

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

    MAUDE report 12344387 ↗
  • InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT PATIENT HAD BILATERAL LASIK PROCEDURE AND PRESENTED AT 1 DAY POST-OP WITH SPECTACLE CORRECTED VISUAL ACUITY (SCVA) OF 20/20 WITH MILD GHOSTING ON RIGHT EYE (OD) WHICH WAS ATTRIBUTED TO DRY EYE AND 20/50 LEFT EYE (OS) SINCE SURGERY. LEFT EYE MRX: -0.50 + 1.25 X 050, 20/20 WITH BLURRY VISION. PATIENT STATED VISION IS LIKE LOOKING THROUGH A CLOUD OR TISSUE PAPER OS. THERE WERE TRACE, PERIPHERAL MICROFOLDS WHICH WAS SMOOTHED AT THE SLIT LAMP WITH NO INTERFACE DEBRIS OR DIFFUSE LAMELLAR KERATITIS (DLK).

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

    MAUDE report 11942483 ↗
  • MalfunctionMay 18, 2021Computer System Security Problem; Computer System Security Problem

    IT WAS REPORTED THAT SYSTEM HAD ERROR MESSAGE JUST AFTER STARTING THE PROCEDURE (LASER HAD BEEN FIRED). CUSTOMER STATED THAT THEY RESTARTED THE SYSTEM HOWEVER THE ISSUE PERSISTED. THEY ABORTED THE PROCEDURE AND THERE WAS NO PATIENT INJURY REPORTED.

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

    MAUDE report 11846173 ↗
  • InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY THE SURGEON THAT ON THE RIGHT EYE OF THE FIRST PATIENT THE LASER DID NOT APPEAR TO TREAT WITH HINGE, BUT APPEARED TO BE A FREE CAP. UPON FURTHER DISCUSSION WITH THE SURGEON HE EXPLAINED THERE WAS SO MUCH FORCE AT HINGE DUE TO BUBBLES. THERE IS A POSSIBILITY A VERTICAL GAS BREAKTHROUGH (VGB) OCCURRED. HE FURTHER STATED THE LASER WAS SERVICED LAST ON (B)(6), 2021.

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

    MAUDE report 11729059 ↗
  • InjuryApr 8, 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 SURGERY ON (B)(6) 2021 WHICH RESULTED IN A THIN FLAP IN THE RIGHT EYE (OD). THE SURGERY WAS COMPLETED THE SAME DAY BY SWITCHING TO PHOTOREFRACTIVE KERATECTOMY (PRK).

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

    MAUDE report 11633179 ↗
  • InjuryFeb 17, 2021Failure to Calibrate

    IT WAS REPORTED ON (B)(6) 2021 THAT THE IFS Z-CAL MOVED DURING THE DAY AND THICKNESS WAS 130MM. THE SURGEON REPORTED THAT A PATIENT HAD A TORN FLAP FROM 8 TO 10 O'CLOCK ON ONE EYE. THE FLAP WAS PUT BACK DOWN AND COVERED WITH A BANDAGE CONTACT LENS.

    Patient problems: Eye Injury

    MAUDE report 11337670 ↗
  • InjuryOct 5, 2020Adverse 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 SURGERY ON (B)(6) 2020 AND PRESENTED ON (B)(6) 2020 WITH VERTICAL STRIAE IN THE LEFT EYE (OS). THE PATIENT COMMENTED THE LEFT EYE WAS BLURRY AND HAD GLARE. IT WAS STATED THAT THE PATIENT HAD LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) WITH OS 20/30 (PRE-OP 20/20). SECONDARY SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2020 TO STRETCH OUT THE WRINKLES. PATIENT SYMPTOMS DID NOT INTERFERE WITH DAILY ACTIVITIES. BCVA FROM (B)(6) 2020: RIGHT EYE PRE-OP 20/20 -1.00 X -2.25 X 177, LEFT EYE PRE-OP 20/20 -.50 X -2.25 X 179.

    Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

    MAUDE report 10627738 ↗
  • InjuryOct 2, 2020Adverse 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 SURGERY ON (B)(6) 2020 AND PRESENTED ON (B)(6) 2020 WITH VERTICAL STRIAE IN THE RIGHT EYE (OD). THE PATIENT COMMENTED THE LEFT EYE WAS GREAT, BUT THE RIGHT EYE WAS BLURRY. IT WAS STATED THAT THE PATIENT HAD LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) WITH OD DISTANCE 20/60 (PRE-OP 20/20). SECONDARY SURGICAL PROCEDURE WAS PERFORMED ON (B)(6) 2020 TO STRETCH OUT THE WRINKLES. PATIENT SYMPTOMS DID NOT INTERFERE WITH DAILY ACTIVITIES.

    Patient problems: Blurred Vision; No Code Available; Visual Impairment

    MAUDE report 10623823 ↗
  • InjurySep 24, 2020Adverse 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 SURGERY ON (B)(6) 2020 AND PRESENTED ON (B)(6) 2020 WITH DIFFUSE LAMELLAR KERATITIS (DLK) IN BOTH EYES (OU) BUT MORE PRONOUNCED IN THE LEFT EYE (OS), POST TREATMENT. MEDROL PACK, AN ORAL STEROID WAS PRESCRIBED AND THE TOPICAL STEROID DOSAGE WAS INCREASED. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT COMPLAINED OF BLURRY AND FOGGY VISION. PATIENT REPORTED SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. BCVA FROM (B)(6) 2020 RIGHT EYE PRE-OP 20/20 1.75 X -.50 X 82, LEFT EYE PRE-OP 20/20 2.25 X -1.00 X 93.

    Patient problems: Blurred Vision; Keratitis

    MAUDE report 10583301 ↗
  • MalfunctionAug 19, 2020Mechanical Problem; Mechanical Problem

    IT WAS REPORTED THAT A LASER VISION CORRECTION PATIENT HAD SURGERY ON (B)(6) 2020 AND DURING THE RASTER PATTERN AN OSCILLATOR MODE LOCK ERROR APPEARED AND WOULD NOT ALLOW THE SITE TO CONTINUE. THE SURGEON ABORTED THE REMAINDER OF THE PROCEDURE. THE PATIENT¿S ONE DAY POST-OP BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/20 WITH NO HARM FOUND. PATIENT WILL RETURN AT A FUTURE DATE AND SURGEON COMPETE ANOTHER FLAP WITH A DEPTH OF 150UM.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10425500 ↗
  • InjuryAug 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT TWO PATIENTS PRESENTED WITH DIFFUSE LAMELLAR KERATITIS (DLK AND BOTH PATIENTS WERE TREATED WITH TOPICAL STEROIDS. IN ADDITION, IT WAS REPORTED THAT ONE PATIENT WAS A FEMALE AND ONE WAS A MALE. ONE HAD STAGE 2 DLK AND THE OTHER HAD STAGE 3 DLK. ONE WAS PRESCRIBED MEDROL PACK AND HAD A FLAP LIFT AND RINSE PERFORMED. THE ADDITIONAL INFORMATION THAT WAS PROVIDED, DID NOT INDICATE WHICH OF THE PATIENTS HAD THE SURGICAL INTERVENTION ( FLAP LIFT AND RINSE) OR MEDROL PRESCRIBED; NOR WHAT STAGE OF DLK FOR EACH GENDER. ADDITIONAL FOLLOW ATTEMPTS WERE MADE WITH THE ACCOUNT TO OBTAIN SPECIFIC PATIENT INFORMATION HOWEVER, NO RESPONSE WAS RECEIVED FROM THE ACCOUNT. THIS REPORT IS FOR MALE PATIENT #2 USING THE FEMTO LASER. A SEPARATE REPORT WILL BE FILED FOR MALE PATIENT #2 USING THE EXCIMER LASER. PATIENT #1 WAS SUBMITTED UNDER MANUFACTURING REPORT # 3006695864-2020-00381 AND 3006695864-2020-00382.

    Patient problems: Keratitis

    MAUDE report 10401712 ↗
  • InjuryAug 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT TWO PATIENTS PRESENTED WITH DIFFUSE LAMELLAR KERATITIS (DLK AND BOTH PATIENTS WERE TREATED WITH TOPICAL STEROIDS. IN ADDITION, IT WAS REPORTED THAT ONE PATIENT WAS A FEMALE AND ONE WAS A MALE. ONE HAD STAGE 2 DLK AND THE OTHER HAD STAGE 3 DLK. ONE WAS PRESCRIBED MEDROL PACK AND HAD A FLAP LIFT AND RINSE PERFORMED.  THE ADDITIONAL INFORMATION THAT WAS PROVIDED, DID NOT INDICATE WHICH OF THE PATIENTS HAD THE SURGICAL INTERVENTION ( FLAP LIFT AND RINSE) OR MEDROL PRESCRIBED; NOR WHAT STAGE OF DLK FOR EACH GENDER. ADDITIONAL FOLLOW ATTEMPTS WERE MADE WITH THE ACCOUNT TO OBTAIN SPECIFIC PATIENT INFORMATION HOWEVER, NO RESPONSE WAS RECEIVED FROM THE ACCOUNT.  THIS REPORT IS FOR FEMALE PATIENT #1 USING THE FEMTO LASER. A SEPARATE REPORT WILL BE FILED FOR FEMALE PATIENT #1 USING THE EXCIMER LASER.  PATIENT #2 WAS SUBMITTED UNDER MANUFACTURING REPORT # 3006695864-2020-00383 AND 3006695864-2020-00384.

    Patient problems: Keratitis

    MAUDE report 10401610 ↗
  • InjuryAug 13, 2020Adverse 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 SURGERY ON (B)(6) 2020 AND PRESENTED ON (B)(6) 2020 WITH BLURRY VISION OF THE RIGHT EYE. IT WAS STATED THAT A TRANSCRIPTION ERROR RESULTED IN THE WRONG AXIS BEING TREATED. THE PATIENT COMMENTED THAT LEFT EYE WAS GREAT, BUT RIGHT EYE WAS BLURRY. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) THE PATIENT REPORTED THAT SYMPTOMS WERE SIGNIFICANTLY INTERFERING WITH DAILY ACTIVITIES AND WAS SCHEDULED FOR A RE-TREAT ON (B)(6) 2020. BCVA FROM (B)(6) 2020: RIGHT EYE PRE-OP 20/20 1.00 X -3.75 X 25, LEFT EYE PRE-OP 20/20 1.75 X -4.00 X 145.

    Patient problems: Blurred Vision

    MAUDE report 10400082 ↗
  • InjuryAug 7, 2020Adverse 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 SURGERY ON (B)(6) 2020 AND PRESENTED ON (B)(6) 2020 WITH VERTICAL STRIAE IN PATIENT'S LEFT EYE (OS) AT A POST OP EXAM. PATIENT'S CHIEF COMPLAINT WAS OF BLURRY VISION. PATIENT CANNOT SEE ANYTHING OUT OF LEFT EYE. IT WAS STATED THAT THE PATIENT HAD A LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). PATIENT REPORTED SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. SECONDARY SURGICAL INTERVENTION IS REQUIRED. BCVA FROM (B)(6) 2020. RIGHT EYE POST-OP 20/20. LEFT EYE POST-OP 20/30.

    Patient problems: Blurred Vision; No Code Available; Visual Impairment

    MAUDE report 10379514 ↗
  • InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PROCEDURE IN PATIENT'S LEFT EYE (OS) RESULTED IN AN INCOMPLETE FLAP. CUSTOMER SUSPECTS THIS WAS DUE TO PATIENT PROFUSELY SWEATING. RIGHT EYE (OD) WAS COMPLETED SUCCESSFULLY AND PATIENT IS RETURNING FOR PHOTOREFRACTIVE KERATECTOMY (PRK) ON LEFT EYE.

    Patient problems: No Code Available

    MAUDE report 10314245 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.