KAMRA inlayRecalls & reported problems across all models

We found 2 models of KAMRA inlay by Bausch & Lomb Incorporated in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Jan 5, 2016 and Mar 29, 2018 — classified as 29 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported KAMRA inlay problems

KAMRA inlay models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• KAMRA inlay 76043

  Implant, Corneal, Refractive
  27 reports
• KAMRA inlay 76225-10

  Implant, Corneal, Refractive
  2 reports

Recent KAMRA inlay adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryOct 12, 2017No Apparent Adverse Event; No Apparent Adverse Event

  THE REPORTED INFORMATION STATED THE INLAY WAS EXPLANTED FROM A FEMALE PATIENT DUE TO AN INFILTRATE ADJACENT TO THE INLAY.

  Patient problems: Corneal Infiltrates

  MAUDE report 6946270 ↗
• 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 11, 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)YEAR OLD MALE PATIENT AT THE PATIENT'S REQUEST APPROXIMATELY 14 DAYS POSTOPERATIVELY DUE TO PERSISTENT COMPLAINTS OF POOR NEAR AND DISTANCE VISION.

  Patient problems: Visual Impairment

  MAUDE report 6790287 ↗
• 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 ↗

Other Bausch & Lomb Incorporated products

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• Akreos IOL8 models · 10 reports · 1 recall
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