KAMRA inlay 76043Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00813359020007), received between Jan 5, 2016 and Mar 29, 2018 — classified as 27 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryMar 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FROM THE LEFT EYE OF A (B)(6) FEMALE PATIENT APPROXIMATELY 10 MONTHS POSTOPERATIVELY DUE TO BLURRY VISION AT NEAR AND DISTANCE AND DIFFICULTY ADAPTING. PRIOR TO THE EXPLANT THE PATIENT WAS BEING TREATED FOR DRY EYE AND HYPEROPIC SHIFT.

  Patient problems: Blurred Vision

  MAUDE report 7382290 ↗
• InjurySep 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FROM THE LEFT EYE OF A (B)(6) MALE PATIENT APPROXIMATELY 9 MONTHS POST OPERATIVELY DUE TO A PERSISTANT CORNEAL ULCER AND SUSPECTED FUNGAL INFECTION OVER THE INLAY.

  Patient problems: Corneal Ulcer; Fungal Infection

  MAUDE report 6854103 ↗
• InjuryAug 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FROM THE LEFT EYE OF A (B)(6) MALE PATIENT APPROXIMATELY EIGHT (8) MONTHS POSTOPERATIVELY DUE TO AN INFLAMMATORY REACTION ON THE INLAY INTERFACE WITH DECREASED VISUAL ACUITY, INCREASED OCULAR SCATTER, AND PRESCRIPTION.

  Patient problems: Corneal Edema

  MAUDE report 6777136 ↗
• InjuryJun 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE KAMRA INLAY WAS EXPLANTED FROM THE RIGHT EYE OF A (B)(6) YEAR OLD FEMALE PATIENT APPROXIMATELY 20 DAYS POSTOPERATIVELY DUE TO AN EPITHELIAL INGROWTH. THE PATIENT PLANS TO HAVE ANOTHER KAMRA INLAY IMPLANTED AFTER THE EPITHELIAL INGROWTH HAS HEALED.

  Patient problems: Impaired Healing

  MAUDE report 6639121 ↗
• InjuryJun 13, 2017No Apparent Adverse Event; No Apparent Adverse Event

  THE KAMRA INLAY WAS EXPLANTED FROM THE LEFT EYE OF A MALE PATIENT APPROXIMATELY 1 MONTH AND 2 WEEKS POSTOPERATIVELY DUE TO VARIOUS VISUAL DISTURBANCES INCLUDING THE FOLLOWING: GLARE, HALOS, HAZE, AND BLURRY VISION.

  Patient problems: Visual Impairment

  MAUDE report 6639115 ↗
• InjuryMay 2, 2017No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED DUE TO EPITHELIALS IN THE POCKET.

  Patient problems: Impaired Healing

  MAUDE report 6539139 ↗
• InjuryFeb 16, 2017No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FROM THE RIGHT EYE OF A (B)(6) YEAR OLD FEMALE PATIENT APPROXIMATELY THREE (3) MONTHS AND 20 DAYS DUE TO PERSISTENT CORNEAL HAZE (POCKET HAZE), BLURRED VISION, AND EPITHELIAL DEFECT. ONSET OF THE EPITHELIAL DEFECT IS UNKNOWN. ON (B)(6) 2016, IT WAS REPORTED THAT THE EPITHELIAL DEFECT HAD CLOSED. THE CORNEAL HAZE WAS TREATED WITH AN EXTENSIVE STEROID REGIMEN: DUREZOL QUID ALONG WITH MURO AND ALPHAGAN TO CONTROL INTRAOCULAR PRESSURE. IT WAS NOTED DURING THE (B)(6) 2016 VISIT, THE HAZE WAS GONE HOWEVER, THE PATIENT DEVELOPED A CATARACT DUE TO THE STEROID REGIMEN. PATIENT'S VISION HAS IMPROVED TO A BCDVA OF 20/50 AS REPORTED ON (B)(6) 2016. THE PATIENT HAS SINCE UNDERGONE CATARACT SURGERY AND THE REPORTED VISUAL ACUITY IS NOW 20/20.

  Patient problems: Corneal Clouding/Hazing

  MAUDE report 6337824 ↗
• InjuryFeb 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FROM THE RIGHT EYE OF A (B)(6) MALE APPROXIMATELY FOUR (4) MONTHS POSTOPERATIVELY DUE TO PERSISTENT POCKET HAZE. IT WAS ALSO NOTED THAT IT TOOK THREE (3) ATTEMPTS TO IMPLANT THE INLAY SINCE THE INLAY KEPT FOLDING. THIS RESULTED IN LENGTHY MANIPULATION IN PATIENT'S EYE. THE PATIENT ALSO UNDERWENT A PRK PROCEDURE ON THE SAME DAY AS THE KAMRA INLAY IMPLANTATION. THE CORNEAL HAZE WAS TREATED WITH AN EXTENSIVE STEROID REGIMEN: DUREZOL QID ALONG WITH MURO AND ALPHAGAN TO CONTROL INTRAOCULAR PRESSURE. IT WAS REPORTED THAT THE PATIENT'S HAZE HAS DISSIPATED DRAMATICALLY AND THE LAST BDCVA RECORDED ON (B)(6) 2017 WAS 20/60.

  Patient problems: Corneal Clouding/Hazing

  MAUDE report 6336132 ↗
• InjuryDec 7, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FROM THE LEFT EYE OF A (B)(6) FEMALE PATIENT APPROXIMATELY FIVE (5) MONTHS POSTOPERATIVELY DUE TO BLURRED VISION.

  Patient problems: Blurred Vision

  MAUDE report 6152350 ↗
• InjuryOct 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FROM THE LEFT EYE OF A (B)(6) YEAR OLD FEMALE PATIENT APPROXIMATELY 24 DAYS POSTOPERATIVELY DUE TO AN EPITHELIAL INGROWTH.

  Patient problems: Impaired Healing

  MAUDE report 6060566 ↗
• InjuryOct 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED INFORMATION: PATIENT'S HUSBAND REPORTED ON 11/10/2016 THAT THE PATIENT HAS A CORNEAL ULCER AND VISION LOSS ASSOCIATED WITH A POSTOPERATIVE INFECTION. THE PATIENT HAS SINCE CHANGED PHYSICIANS. THE IMPLANTING CLINIC REPORTED THE NECROTIC CORNEAL TISSUE IN THE LEFT EYE WAS DEBULKED AND AN AMBIODISK WAS PLACED IN THE LEFT EYE.

  Patient problems: Corneal Ulcer; Intraocular Infection; Loss of Vision

  MAUDE report 6049016 ↗
• InjurySep 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FOR A (B)(6) YEAR OLD FEMALE PATIENT APPROXIMATELY 24 DAYS POSTOPERATIVELY DUE TO AN INFECTION, ABRASION, AND HAZE OVER THE INLAY.

  Patient problems: Corneal Abrasion; Corneal Ulcer; Intraocular Infection

  MAUDE report 5984924 ↗
• InjurySep 23, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FROM THE RIGHT EYE OF A (B)(6) YEAR OLD FEMALE PATIENT APPROXIMATELY ONE MONTH AND TWENTY DAYS POSTOPERATIVELY DUE TO AN INFECTION.

  Patient problems: Corneal Abrasion; Corneal Clouding/Hazing; Impaired Healing; Intraocular Infection

  MAUDE report 5975497 ↗
• InjuryAug 26, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FROM THE RIGHT EYE OF A (B)(6) MALE PATIENT ONE (1) MONTH AND 16 DAYS POSTOPERATIVELY DUE TO AN EPITHELIAL INGROWTH.

  Patient problems: Impaired Healing

  MAUDE report 5905510 ↗
• InjuryAug 4, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FROM THE RIGHT EYE OF A (B)(6)YEAR OLD MALE PATIENT APPROXIMATELY EIGHT (8) MONTHS POSTOPERATIVELY, DUE TO BOTH DISTANCE AND NEAR VISION IMPAIRED AND MYOPIC SHIFT.

  Patient problems: Visual Impairment

  MAUDE report 5848846 ↗
• InjuryJul 15, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FROM THE RIGHT EYE OF A (B)(6) YEAR OLD MALE PATIENT APPROXIMATELY 21 DAYS POSTOPERATIVELY DUE TO CORNEAL HAZE.

  Patient problems: Corneal Clouding/Hazing

  MAUDE report 5799220 ↗
• InjuryJul 15, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH SUB-EPITHELIAL STERILE INFILTRATES AND COMPLAINTS OF PHOTOPHOBIA IN THE RIGHT EYE, FIVE WEEKS POSTOPERATIVELY.

  Patient problems: Corneal Infiltrates

  MAUDE report 5799217 ↗
• InjuryJul 14, 2016No Apparent Adverse Event; No Apparent Adverse Event

  THE INLAY WAS EXPLANTED APPROXIMATELY ONE (1) MONTH POSTOPERATIVELY DUE TO VISUAL DISTURBANCES (BLUR, HAZE, AND GHOSTING), FOREIGN BODY SENSATION, AND VISUAL ACUITY IMPAIRMENT. AS REPORTED ON 06/03/2016, THE PATIENT'S VISION HAS IMPROVED POST EXPLANT.

  Patient problems: Blurred Vision; Foreign Body Sensation in Eye; Loss of Vision; Visual Disturbances

  MAUDE report 5796963 ↗
• InjuryJul 1, 2016No Apparent Adverse Event; No Apparent Adverse Event

  THE PATIENT WAS REPORTED TO HAVE DIFFICULTY SEEING AND WAS TREATED WITH DUREZOL FOLLOWED BY RESTASIS AND ANOTHER ROUND OF STEROIDS.

  Patient problems: Loss of Vision

  MAUDE report 5765225 ↗
• InjuryJun 10, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTED INFORMATION STATED THAT THE INLAY WAS EXPLANTED FROM THE LEFT EYE OF A (B)(6) YEAR OLD MALE PATIENT APPROXIMATELY EIGHT (8) MONTHS POSTOPERATIVELY DUE TO POOR CORNEAL HEALING CAUSED BY PERSISTENT DRY EYE. IT WAS NOTED THAT THE PATIENT HAD DIFFICULTY COMPLYING WITH THE POST-OPERATIVE REGIMEN.

  Patient problems: Dry Eye(s)

  MAUDE report 5717249 ↗
• InjuryJun 10, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FROM THE LEFT EYE OF A (B)(6) FEMALE PATIENT APPROXIMATELY FIVE (5) MONTHS POSTOPERATIVELY DUE TO CORNEAL HAZE AND BLURRED VISION.

  Patient problems: Corneal Clouding/Hazing; Visual Impairment

  MAUDE report 5717244 ↗
• InjuryJun 10, 2016No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FROM THE LEFT EYE OF A (B)(6) MALE PATIENT APPROXIMATELY THREE (3) MONTHS POSTOPERATIVELY DUE TO AN INFECTION.

  Patient problems: Intraocular Infection

  MAUDE report 5717234 ↗
• InjuryApr 14, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED APPROXIMATELY FOUR (4) MONTHS POSTOPERATIVELY FROM THE LEFT EYE OF A (B)(6) FEMALE PATIENT DUE TO CORNEAL THINNING THAT PROGRESSED TO A CORNEAL MELT.

  Patient problems: Corneal Decompensation

  MAUDE report 5577262 ↗
• InjuryApr 11, 2016No Apparent Adverse Event; No Apparent Adverse Event

  PATIENT HAD A KAMRA INLAY IMPLANTATION AND PRK (PHOTOREFRACTIVE KERATECTOMY) PROCEDURE ON THE RIGHT EYE. ONE (1) DAY POSTOPERATIVELY IT WAS REPORTED THAT THE PATIENT HAD STAGE 2 DLK (DIFFUSE LAMELLAR KERATITIS). ON (B)(6) 2016, THE PATIENT WAS SEEN FOR A SECOND OPINION AND WAS DIAGNOSED WITH STAGE 4 DLK. PATIENT WAS TREATED WITH TOPICAL AND ORAL PREDNISOLONE FOR FOUR (4) MONTHS.

  Patient problems: Keratitis

  MAUDE report 5568781 ↗
• InjuryApr 1, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FROM THE EYE OF A (B)(6) YEAR OLD MALE PATIENT APPROXIMATELY 16 DAYS POSTOPERATIVELY DUE TO AN EPITHELIAL INGROWTH.

  Patient problems: Impaired Healing

  MAUDE report 5541835 ↗