IDESIGN RS G301Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474651432), received between Mar 12, 2020 and Oct 16, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Environmental Compatibility Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (P930016); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2024Environmental Compatibility Problem; Environmental Compatibility Problem

  IT WAS REPORTED THAT A PATIENT HAD CUSTOMVUE MYOPIC LASIK ON (B)(6) 2024 ON BOTH EYES (OU) AND WAS OVERCORRECTED. ON (B)(6) 2024 PATIENT HAD A CONVENTIONAL RETREATMENT OU. RIGHT EYE IS FINE BUT LEFT EYE HAD EPI INGROWTH. IT WAS ALSO REPORTED THAT PATIENT HAS A HISTORY OF DRY EYES. DURING THE TIME OF SURGERY CUSTOMER WAS ALSO HAVING HEATING, VENTILATION, AND AIR CONDITIONING (HVAC) AND OPERATING ROOM TEMPERATURE WAS GENERALLY KEPT BELOW THE RECOMMENDED RANGE BUT HAS NOW BEEN REPAIRED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS AGAINST THE IDESIGN. A SEPARATE REPORT WILL BE FILED AGAINST THE STAR LASER.

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

  MAUDE report 20466092 ↗
• InjuryApr 11, 2023Adverse 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) 2022 AND WAS OVERCORRECTED IN THE LEFT EYE. IDESIGN MANIFEST REFRACTION (MR) -9.12 +2.90 X 100, MR. -8.25 +2.75 97 BEST CORRECTED VISUAL ACUITY (BCVA) 20/20. AN ENHANCEMENT WAS PERFORMED ON (B)(6)2022. IDESIGN MR -.10 +1.14 X79, MR +1.25 SPH. PHYSICIAN ADJ +.50. PATIENT ENDED UP WITH 20/25 UNCORRECTED VISUAL ACUITY (UCVA). NO REFRACTION HAS BEEN DONE AND PATIENT IS NOT DUE TO RETURN FOR ANOTHER 6 MONTHS. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE IDESIGN. A SEPARATE REPORT WILL BE FILED FOR THE EXCIMER LASER.

  Patient problems: Visual Impairment

  MAUDE report 16710855 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD SURGERY ON SEPTEMBER 8, 2022 AND WAS OVERCORRECTED ON BOTH EYES. RIGHT EYE (OD) - IDESIGN MANIFEST REFRACTION (MR) -2.96 +0.52 X 29, MR -2.91 +.25 X 10 20/20 BEST CORRECTED VISUAL ACUITY (BCVA). LEFT EYE (OS) - IDESIGN MR -2.93 +0.18 X 172, MR -3.16 SPH. 20/20 BCVA. ENHANCEMENT DONE ON DECEMBER 22, 2022 FOR LEFT EYE ONLY. IDESIGN MR +2.54 +1.45 X 0, MR +1.84 +1.00 X 10. PHYSICIAN ADJ -0.50. AS OF (B)(6) 2023 THE PATIENT WAS SEEING 20/30 UNCORRECTED VISUAL ACUITY (UCVA), THEY HAVE NOT DONE AN MR ON THE PATIENT. WHILE THE OD WAS NOT ENHANCED, THE CURRENT MR IS +1.25 +.50 X15 WITH 20/20 BCVA. HOWEVER, THE PATIENT WEARS A CONTACT LENS (CL) AND ONLY SEES 20/30 WITH THE CL. PATIENT DECLINED AN ENHANCEMENT ON THE OD. THE PATIENT DOES APPEAR TO HAVE A GOOD BIT OF HIGHER ORDER ABERRATIONS (HOAS) IN BOTH EYES. THE IDESIGN SE FOR THE OS WAS -2.84 AND THE EFF BLUR WAS 4.14 D. PRE-OP K¿S FOR THE OS WERE 45.30/46.57 X168 AND AFTER THE ENHANCEMENT WERE MEASURING 39.30/41.90 X175. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE IDESIGN. A SEPARATE REPORT WILL BE FILED FOR THE EXCIMER LASER.

  Patient problems: Visual Impairment

  MAUDE report 16710650 ↗
• InjurySep 28, 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 WAS TREATED SEPTEMBER 2020 WITH IDESIGN AND PHOTOREFRACTIVE KERATECTOMY (PRK) THAT WAS OVERCORRECTED. ORIGINAL RX WAS -1.25 +0.75 AND THE PATIENT ENDED UP BEING +.25 +.75. PATIENT WAS RETREATED IN MAY 2021. NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) REPORTED. PATIENT IS DOING WELL. THIS REPORT IS FOR THE IDESIGN. A SEPARATE REPORT WILL BE FILED FOR THE EXCIMER LASER.

  Patient problems: Visual Impairment

  MAUDE report 12544794 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS TREATED (B)(6) 2020 WITH IDESIGN AND PHOTOREFRACTIVE KERATECTOMY (PRK) THAT WAS OVERCORRECTED. THE PATIENT WAS RETREATED IN (B)(6) 2021 AND CURRENTLY IS DOING WELL. ORIGINAL RIGHT (OD) EYE TREATMENT (RX) WAS -6.00 +0.25 AND THE PATIENT ENDED UP BEING +1.25 +.25. THERE WAS NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) REPORTED. THIS REPORT IS FOR THE IDESIGN SYSTEM. A SEPARATE REPORT WILL BE SUBMITTED FOR EXCIMER LASER SYSTEM.

  Patient problems: Visual Impairment

  MAUDE report 12544639 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CUSTOMER WAS UNABLE TO CAPTURE A PATIENT WITH THE IDESIGN AND WANTED TO MAKE SURE THIS WAS NOT A TRAINING ISSUE. CLINICAL WENT THROUGH STEPS AT TRYING TO GET A CAPTURE ON THIS PATIENT. THE FIDUCIALS WERE NOT CLEAR AND WERE DISTORTED AND WAS ONLY ABLE TO SEE 2 FIDUCIALS FOR THE MOST PART, AT TIMES A PARTIAL 3RD. CUSTOMER TRIED CAPTURING WITH LIGHTS ON AND OFF, WITH ARTIFICIAL TEARS AND WITHOUT AND HAD THEM GAZE BEYOND THE TARGET WITH COUNTING. CUSTOMER TOOK OVER 30 SCANS AND WAS ABLE TO GET 2 SCANS, BUT BOTH WERE OUTSIDE OF THE APPROVED TREATMENT RANGE WITH OVER 6 DIOPTERS OF CYLINDER. THIS PATIENT HAS BEEN BEING FOLLOWED SINCE LAST YEAR. THE PATIENT WAS ORIGINALLY ALMOST A PLANO AND WAS TREATED FOR MONO VISION. THEY ATTEMPTED A CONVENTIONAL TREATMENT WITH THE STAR EXCIMER AND WANTED TO INDUCE -2.25 DIOPTERS OF SPHERE TO MAKE THIS EYE FOR NEAR VISION. THE PATIENT NOW IS UNABLE TO BE REFRACTED AND WENT FROM HAVING 20/20 VISION IN THE RIGHT EYE TO 20/100. THE ORIGINAL SURGERY DATE WAS IN (B)(6) OF 2019. CLINICAL EXPLAINED TO DOCTOR THAT THERE WAS NOTHING FURTHER IN ASSISTING IN CAPTURING PATIENT'S EYE. DOCTOR WAS HOPING FOR SOME OUTSIDE OF THE BOX CAPTURING TO GET

  Patient problems: Visual Impairment

  MAUDE report 10870279 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED 17 OVERCORRECTIONS. CUSTOMER MENTIONED GETTING OVERCORRECTIONS OF 1.00-1.50 DIOPTERS AND OCCASIONAL 2 DIOPTERS. 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 10512097 ↗
• InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED A CASE OF OVER-CORRECTION FOLLOWING IDESIGN ILASIK TREATMENT. A RE-TREATMENT WAS PERFORMED AND THE PATIENT IS DOING WELL POST-OP. THERE WAS NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) REPORTED. THIS REPORT IS FOR IDESIGN AWS SYSTEM. A SEPARATE REPORT WILL BE SUBMITTED FOR THE EXCIMER LASER SYSTEM.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 10382161 ↗
• InjuryMar 12, 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 WHICH RESULTED IN 2 DIOPTERS OF INDUCED ASTIGMATISM IN THE RIGHT EYE. THE CASE WAS PHOTOREFRACTIVE KERATECTOMY (PRK) UTILIZING AMOILS BRUSH TO REMOVE EPITHELIUM. THIS REPORT IS FOR THE IDESIGN. A SEPARATE REPORT WILL BE FILED FOR THE EXCIMER LASER.

  Patient problems: No Code Available

  MAUDE report 9825496 ↗
• InjuryMar 12, 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 WHICH RESULTED IN 2 DIOPTERS OF INDUCED ASTIGMATISM IN THE RIGHT EYE. THE PATIENT WAS IOL IMPLANT. THE CASE WAS PHOTOREFRACTIVE KERATECTOMY (PRK) UTILIZING AMOILS BRUSH TO REMOVE EPITHELIUM. PRE OP MANIFEST: -2.50 +4.25 X 100. THIS REPORT IS FOR THE IDESIGN. A SEPARATE REPORT WILL BE FILED FOR THE EXCIMER LASER.

  Patient problems: No Code Available

  MAUDE report 9824738 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P930016. One submission often covers many models, so check the product and lot details in each record.

• Z-0443-2022 · Oct 21, 2021 · Open, Classified
  iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United S
• Z-1139-2008 · Dec 13, 2007 · Terminated
  AMO VISX STAR Excimer Laser System, manufactured by VISX, Santa Clara, CA 95051