Raindrop Near Vision Inlay RD1-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 10850394006013), received between Sep 28, 2016 and Jan 24, 2018 — classified as 126 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (62 reports).

2 other recalls cover devices cleared under the same FDA submission (P150034); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 154 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2017. WITHIN THE FIRST 2 POSTOPERATIVE WEEKS THE PATIENT PRESENTED WITH INFERIOR INLAY DECENTRATION AND INLAY REPOSITIONING WAS PLANNED. DURING THIS PROCEDURE INFLAMMATION WAS OBSERVED IN THE INTERFACE IN THE AREA OF THE INLAY, LIKELY DUE TO A CORNEAL ABRASION A FEW DAYS PRIOR. IN ADDITION, EPITHELIAL INGROWTH WAS OBSERVED NEAR THE CORNEAL FLAP HINGE. ON (B)(6) 2017, THE INLAY WAS EXPLANTED AND A REPLACEMENT INLAY WILL BE IMPLANTED ONCE THE INFLAMMATION RESOLVES AND THE EYE IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Inflammation

  MAUDE report 7217652 ↗
• InjuryJan 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2017. IT SHOULD BE NOTED THAT LASIK SURGERY WAS PERFORMED ON THIS EYE CONCURRENT WITH INLAY IMPLANTATION. ON (B)(6) 2017, THE PATIENT PRESENTED WITH SLIGHT CENTRAL AND SUPERIOR CORNEAL HAZE IN THE OPERATIVE EYE AND TOPICAL STEROIDS WERE PRESCRIBED. THE PATIENT WAS EXAMINED ON (B)(6) 2017 AT WHICH TIME HIS BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) DECREASED FROM 20/20 (PREOPERATIVELY) TO 20/70-; TOPICAL STEROIDS WERE CONTINUED TO TREAT THE CORNEAL HAZE. AT LAST EXAMINATION ON (B)(6) 2018, THE CORNEAL HAZE RESOLVED, BCDVA IMPROVED TO 20/25-2, AND THE INLAY REMAINED IMPLANTED. THE SURGEON BELIEVES THAT CONCURRENT LASIK MAY BE A CONTRIBUTING FACTOR.

  Patient problems: Corneal Clouding/Hazing; Visual Impairment

  MAUDE report 7217644 ↗
• InjuryJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY ON (B)(6) 2017. POSTOPERATIVELY, THE PATIENT HAS PRESENTED WITH DENSE CENTRAL CORNEAL HAZE AND THE INLAY IS SCHEDULED TO BE EXPLANTED ON (B)(6) 2018. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Corneal Clouding/Hazing

  MAUDE report 7206931 ↗
• InjuryJan 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2017. TWO MONTHS POSTOPERATIVELY, THE PATIENT WAS TREATED WITH TOPICAL STEROIDS FOR INFLAMMATION INFERIOR TO THE INLAY. FOUR MONTHS POSTOPERATIVELY THE PATIENT WAS DIAGNOSED WITH (B)(6) IN THE OPERATIVE EYE AND STEROIDS AND ANTIVIRAL MEDICATIONS WERE PRESCRIBED. ONE WEEK LATER THE SURGEON WAS UNABLE TO VISUALIZE THE INLAY UNDER THE LASIK FLAP; INTERVENTION WAS REQUIRED TO AMPUTATE THE FLAP ON (B)(6) 2017. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Herpes; Inflammation

  MAUDE report 7204590 ↗
• InjuryJan 17, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE RIGHT EYE ON (B)(6) 2017. POSTOPERATIVELY THE INLAY DECENTERED 2 MM INFERIORLY. IN ADDITION, THE PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) DECREASED FROM 20/20 (PREOPERATIVELY) TO 20/30 IMMEDIATELY PRIOR TO INLAY EXPLANTATION ON (B)(6) 2017. ACCORDING TO THE SURGEON, POOR FIXATION DURING SURGERY WAS A CONTRIBUTING FACTOR. AT LAST EXAMINATION ON (B)(6) 2018, BCDVA IMPROVED TO 20/20 WITH A BANDAGE CONTACT LENS IN PLACE AND THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Loss of Vision

  MAUDE report 7202701 ↗
• MalfunctionJan 17, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A REPLACEMENT RAINDROP CORNEAL INLAY WAS IMPLANTED IN THE PATIENT'S LEFT EYE ON (B)(6) 2017; THE PROCEDURE WAS UNEVENTFUL AND PROPER INLAY CENTRATION WAS VERIFIED. AT SOME POINT DURING THE FIRST POSTOPERATIVE WEEK, THE INLAY DECENTERED 0.75 MM INFERIORLY. ON (B)(6) 2017, BCDVA WAS 20/25, WHICH WAS A SIGNIFICANT IMPROVEMENT COMPARED TO THE PRIOR MEASUREMENT OF 20/60. THE INLAY REMAINS IMPLANTED AT THIS TIME. AT LAST EXAMINATION, THE PATIENT PRESENTED WITH DRY EYE AND MILD BLEPHARITIS, BUT THE SURGEON ANTICIPATES A GOOD OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7202632 ↗
• InjuryJan 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2017. THE INLAY WAS EXCHANGED FOR A NEW INLAY 2 WEEKS POSTOPERATIVELY IN ORDER TO ADDRESS INTERFACE DEBRIS. THE SOURCE OF THE DEBRIS IS NOT KNOWN AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7181194 ↗
• MalfunctionJan 10, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE RIGHT EYE ON (B)(6) 2017. ONE DAY POSTOPERATIVELY, THE INLAY WAS NOTED TO BE DECENTERED INFERIORLY. THE INLAY WAS REMOVED ON (B)(6) 2017 AND A REPLACEMENT INLAY WAS SCHEDULED FOR IMPLANTATION THE FOLLOWING WEEK ONCE THE INTERFACE HEALED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7180348 ↗
• MalfunctionJan 10, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2017. ONE WEEK POSTOPERATIVELY, THE INLAY WAS NOTED TO BE DECENTERED INFERIORLY. THE INLAY WAS REMOVED AND REPLACED WITH A NEW INLAY ON (B)(6) 2017. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7180327 ↗
• InjuryJan 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT UNEVENTFUL IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2016. THE INLAY WAS EXPLANTED ON (B)(6) , 2017 DUE TO MODERATE-TO-SIGNIFICANT GLARE AND HALOS. AT LAST EXAMINATION ONE DAY POST EXPLANT, THE VISUAL SYMPTOMS HAD IMPROVED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 7165218 ↗
• InjuryJan 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2016. POSTOPERATIVELY, THE PATIENT REPORTS EXPERIENCING SIGNIFICANT GLARE. THE PATIENT IS ALSO BEING TREATED WITH TOPICAL STEROIDS FOR CORNEAL HAZE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 7164713 ↗
• InjuryJan 3, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT UNDERWENT IMPLANTATION OF THE CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2017. ONE MONTH POSTOPERATIVELY, THE PATIENT HAD A RETINAL DETACHMENT THAT REQUIRED SURGICAL INTERVENTION. AT THE POSTOPERATIVE EXAMINATION FOLLOWING THE RETINAL REPAIR, THE INLAY WAS NOTED TO BE DECENTERED INFERIORLY; ON (B)(6) 2017, THE INLAY WAS SUBSEQUENTLY EXPLANTED. ADDITIONAL INFORMATION IS BEING REQUESTED.

  Patient problems: Retinal Detachment

  MAUDE report 7162901 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT IMPLANTATION OF THE CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2017. THE PATIENT WAS DIAGNOSED WITH TRACE DIFFUSE LAMELLAR KERATITIS 3 DAYS POSTOPERATIVELY; THE FOLLOWING DAY THE FLAP WAS LIFTED, AND THE INLAY WAS REMOVED AND REPLACED WITH A NEW INLAY. THE CAUSE OF THE DLK IS NOT KNOWN AT THIS TIME. ADDITIONAL INFORMATION IS BEING REQUESTED.

  Patient problems: Keratitis

  MAUDE report 7162855 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT UNEVENTFUL IMPLANTATION OF THE CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2016. THE PATIENT PRESENTED WITH MODERATE CENTRAL AND PERIPHERAL CORNEAL HAZE 5 MONTHS POSTOPERATIVELY WITH RECURRENCES ON (B)(6) 2017. THE INLAY WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2017. THE HAZE DID NOT RESULT IN A SIGNIFICANT DECREASE IN BEST CORRECTED DISTANCE VISION (BCDVA). AT LAST EXAMINATION ON (B)(6) 2017, THE HAZE HAD IMPROVED SLIGHTLY.

  Patient problems: Corneal Clouding/Hazing

  MAUDE report 7162843 ↗
• MalfunctionDec 27, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2017. ON (B)(6) 2017, THE INLAY WAS EXCHANGED DUE TO DECENTRATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7149832 ↗
• InjuryDec 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY ON (B)(6) 2017 AND PRESENTED WITH CORNEAL HAZE POSTOPERATIVELY. INTERVENTION WAS PERFORMED ON (B)(6) 2017 TO REMOVE THE INLAY AND REPLACE IT WITH A NEW INLAY AND ADMINISTER MITOMYCIN-C IN THE FLAP INTERFACE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Corneal Clouding/Hazing

  MAUDE report 7149814 ↗
• InjuryDec 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT UNEVENTFUL IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE (B)(6) 2017. THE INLAY WAS EXPLANTED ON (B)(6) 2017 DUE TO DECREASED BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) FROM 20/20 (PREOPERATIVELY) TO 20/30 PRIOR TO EXPLANT. POST INLAY EXPLANTATION, BCDVA RETURNED TO 20/20. THE CAUSE OF THE DECREASED VISION REMAINS UNKNOWN.

  Patient problems: Loss of Vision

  MAUDE report 7149722 ↗
• InjuryDec 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY ON (B)(6) 2017. ON (B)(6) 2017, THE INLAY WAS EXPLANTED IN ORDER TO ADDRESS CORNEAL HAZE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Corneal Clouding/Hazing

  MAUDE report 7149107 ↗
• InjuryDec 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FOLLOW-UP WAS REQUESTED FROM THE SURGEON, WHO PROVIDED THE FOLLOWING ADDITIONAL INFORMATION. THE PATIENT WAS LAST EXAMINED ON (B)(6) 2017 AND THE BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) HAD IMPROVED TO 20/20-1.

  Patient problems: Loss of Vision

  MAUDE report 7148558 ↗
• InjuryDec 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT UNEVENTFUL IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2016. THE PATIENT PRESENTED WITH CORNEAL HAZE AND DECREASED VISUAL ACUITY ON (B)(6) 2017. THE CORNEAL HAZE PERSISTED DESPITE COMPLIANT TREATMENT WITH TOPICAL STEROIDS. AT EXAMINATION ON (B)(6) 2017, THE HAZE WORSENED TO GRADE 2-3+ (CENTRAL). THE PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) DECREASED FROM 20/20 (PREOPERATIVELY) TO 20/30-2 AT ONSET, AND 20/30 IMMEDIATELY PRIOR TO INTERVENTION. THE PATIENT DID NOT RESPOND TO STEROIDS AND ON (B)(6) 2017 THE INLAY WAS REMOVED AND REPLACED WITH A NEW INLAY AND MITOMYCIN-C WAS ADMINISTERED IN THE FLAP INTERFACE. AT LAST EXAMINATION ONE WEEK POST INLAY EXCHANGE, BCDVA WAS 20/50 AND THE CORNEAL HAZE IMPROVED TO MILD. ACCORDING TO THE SURGEON, PRESENCE OF THE INLAY CONTRIBUTED TO THE EVENT.

  Patient problems: Corneal Clouding/Hazing; Loss of Vision

  MAUDE report 7148518 ↗
• InjuryDec 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT UNEVENTFUL IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2017. T HE INLAY WAS EXPLANTED ON (B)(6) 2017 IN ORDER TO ADDRESS CORNEAL HAZE. THE SURGEON REPORTS THE CORNEAL HAZE IS RESOLVING. ADDITIONAL INFORMATION IS BEING REQUESTED.

  Patient problems: Corneal Clouding/Hazing

  MAUDE report 7148434 ↗
• InjuryDec 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT UNEVENTFUL IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE RIGHT EYE ON (B)(6) 2016. THE INLAY WAS EXPLANTED ON (B)(6) 2017 IN ORDER TO ADDRESS INTOLERABLE VISUAL DISTURBANCES (GHOST IMAGES) AND DECREASED PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) FROM 20/20 (PREOPERATIVELY) TO 20/60 IMMEDIATELY PRIOR TO EXPLANT. THE SURGEON REPORTS THE IMAGE GHOSTING HAS RESOLVED AND THE PATIENT IS DOING GREAT . ADDITIONAL INFORMATION IS BEING REQUESTED TO OBTAIN THE POST-EXPLANT BCDVA.

  Patient problems: Loss of Vision; Visual Disturbances

  MAUDE report 7148351 ↗
• InjuryDec 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2016. THE INLAY WAS EXPLANTED 8 MONTHS POSTOPERATIVELY DUE TO INTOLERABLE LIGHT SENSITIVITY, DIPLOPIA, AND POOR NIGHT VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 7119662 ↗
• InjuryDec 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE LEFT EYE ON (B)(6) 2017. IT SHOULD BE NOTED THAT LASIK SURGERY WAS PERFORMED ON THIS EYE CONCURRENT WITH INLAY IMPLANTATION. ON (B)(6) 2017, CORNEAL HAZE WAS OBSERVED OVER THE INLAY AND THE PATIENT REPORTED EXPERIENCING DISABLING VISUAL DISTURBANCES IN BRIGHT DAYLIGHT CONDITIONS; THE INLAY WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2017. AT LAST EXAMINATION 2 WEEKS POST-EXPLANT THE VISUAL DISTURBANCES HAD RESOLVED AND VISION WAS 20/20.

  Patient problems: Corneal Clouding/Hazing; Visual Disturbances

  MAUDE report 7119597 ↗
• InjuryDec 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT UNEVENTFUL IMPLANTATION OF THE RAINDROP CORNEAL INLAY IN THE RIGHT EYE ON (B)(6) 2016. THE INLAY WAS EXPLANTED ON (B)(6) 2017 IN ORDER TO ADDRESS DECREASED BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) FROM 20/20 (PREOPERATIVELY) TO 20/50. POST EXPLANT, BCDVA IMPROVED TO 20/25+.

  Patient problems: Loss of Vision

  MAUDE report 7117505 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150034. One submission often covers many models, so check the product and lot details in each record.

• Z-0865-2019 · Nov 13, 2018 · Terminated
  Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
• Z-1518-2017 · Feb 7, 2017 · Terminated
  Raindrop Near Vision Inlay, Model# RD1-1