RayOne EMV RAO200E (REF RAO200E/+19.0)Recalls & reported problems
Rayner Intraocular Lenses Limited · Class 3 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05029867006685), received between May 20, 2022 and Oct 24, 2025 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (8 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- May 13, 2022Open, Classified
The outer package is mislabeled and the package contains a different IOL strength.
Z-1338-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem8
- Break2
- Product Quality Problem2
- Crack1
- Material Opacification1
- Optical Distortion1
- Optical Problem1
Patient problems
- Visual Impairment11
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2025Crack; Crack
ON 2ND OCTOBER 2025, RAYNER RECEIVED NOTIFICATION FROM ITS TAIWAN DISTRIBUTOR OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT IMMEDIATELY FOLLOWING IMPLANTATION INTO THE EYE A CRACK WAS OBSERVED IN THE OPTIC NECESSITATING LENS EXPLANTATION AND EXCHANGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23377144 ↗MalfunctionMay 28, 2025Optical Problem; Optical Problem
ON 15TH MAY 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE PATIENT REFRACTIVE OUTCOME WAS NOT AS EXPECTED POST-OPERATIVELY NECESSITATING AN ADDITIONAL SURGERY TO EXPLANT AND EXCHANGE THE IOL.
Patient problems: Visual Impairment
MAUDE report 22094781 ↗MalfunctionJan 22, 2025Break; Break
ON 13TH JANUARY 2025, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE TRAILING HAPTIC BROKE DURING IMPLANTATION NECESSITATING EXPLANTATION OF THE IOL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21206730 ↗MalfunctionDec 11, 2024Optical Distortion; Optical Distortion
ON 5TH DECEMBER 2024, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE PROFESSIONAL OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE PATIENT'S POST-OPERATIVE REFRACTIVE OUTCOME WAS NOT AS EXPECTED.
Patient problems: Visual Impairment
MAUDE report 20901515 ↗MalfunctionMar 3, 2024Material Opacification; Material Opacification
ON 13TH FEBRUARY 2024, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT POST-OPERATIVELY OPACIFICATION OF THE IOL WAS OBSERVED AND THAT VISUAL ACUITY DECLINED AS A RESULT NECESSITATING IOL EXPLANTATION.
Patient problems: Visual Impairment
MAUDE report 18823456 ↗MalfunctionOct 3, 2022Break; Break
ON (B)(6) 2022, RAYNER RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILTIY OF AN EVENT THAT OCCURRED DURING USE OF A RAYONE EMV RAO200E. THE EVENT DESCRIPTION PROVIDED STATES THAT THE LENS HAPTIC WAS STUCK IN THE INSERTER AND TORE AFTER ATTEMPT TO PLACE IT IN THE EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15527857 ↗MalfunctionMay 25, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
ON (B)(6) 2022, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY THAT A LENS SUBJECT TO RECALL (REF. (B)(4)/17/2022-001-R) HAD BEEN IMPLANTED. POST-OPERATIVELY, THE PATIENT HAS PRESENTED WITH A REFRACTIVE ERROR.
Patient problems: Visual Impairment
MAUDE report 14495398 ↗MalfunctionMay 25, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
ON 19TH MAY 2022, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY THAT A LENS SUBJECT TO RECALL (REF. 3012304651-05/17/2022-001-R) HAD BEEN IMPLANTED. POST-OPERATIVELY, THE PATIENT HAS PRESENTED WITH A REFRACTIVE ERROR.
Patient problems: Visual Impairment
MAUDE report 14495351 ↗MalfunctionMay 25, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
ON (B)(6) 2022, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY THAT A LENS SUBJECT TO RECALL (REF. 3012304651-05/17/2022-001-R) HAD BEEN IMPLANTED. POST-OPERATIVELY, THE PATIENT HAS PRESENTED WITH A REFRACTIVE ERROR.
Patient problems: Visual Impairment
MAUDE report 14495023 ↗MalfunctionMay 25, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
ON 19TH MAY 2022, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY THAT A LENS SUBJECT TO RECALL (REF. 3012304651-05/17/2022-001-R) HAD BEEN IMPLANTED. POST-OPERATIVELY, THE PATIENT HAS PRESENTED WITH A REFRACTIVE ERROR.
Patient problems: Visual Impairment
MAUDE report 14495000 ↗MalfunctionMay 25, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
ON (B)(6) 2022, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY THAT A LENS SUBJECT TO RECALL (REF. 3012304651-05/17/2022-001-R) HAD BEEN IMPLANTED. POST-OPERATIVELY, THE PATIENT HAS PRESENTED WITH A REFRACTIVE ERROR.
Patient problems: Visual Impairment
MAUDE report 14494992 ↗MalfunctionMay 25, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
ON 19TH MAY 2022, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY THAT A LENS SUBJECT TO RECALL (REF. 3012304651-05/17/2022-001-R) HAD BEEN IMPLANTED. POST-OPERATIVELY, THE PATIENT HAS PRESENTED WITH A REFRACTIVE ERROR.
Patient problems: Visual Impairment
MAUDE report 14494991 ↗MalfunctionMay 25, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
ON (B)(6) 2022, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY THAT A LENS SUBJECT TO RECALL (REF. (B)(4)/17/2022-001-R) HAD BEEN IMPLANTED. POST-OPERATIVELY, THE PATIENT HAS PRESENTED WITH A REFRACTIVE ERROR.
Patient problems: Visual Impairment
MAUDE report 14494730 ↗MalfunctionMay 20, 2022Product Quality Problem; Product Quality Problem
ON 16TH MAY 2022, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A US HEALTHCARE FACILITY THAT A LENS SUBJECT TO RECALL (REF. (B)(4) HAD BEEN IMPLANTED. POST-OPERATIVELY, THE PATIENT HAS PRESENTED WITH A REFRACTIVE ERROR.
Patient problems: Visual Impairment
MAUDE report 14461440 ↗MalfunctionMay 20, 2022Product Quality Problem; Manufacturing, Packaging or Shipping Problem; Product Quality Problem; Manufacturing, Packaging or Shipping Problem
ON (B)(6) 2022, RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM ITS US SALES TEAM THAT A RAYONE EMV RAO200E +19.0D BATCH 012183745 SYSTEM PACK CONTAINED THE INNER BLISTER TRAY (PRELOADED INJECTOR AND IOL) FOR THE RAYONE EMV RAO200E +21.0 D BATCH 012183845. THE PRODUCT AS SUBJECT TO THIS REPORT WAS NOT USED; HOWEVER, IT WAS IDENTIFIED WITHIN THE INITIAL NOTIFICATION THAT PRIOR IMPLANTATION OF A LENS FROM THE SAME BATCH HAD OCCURRED. INVESTIGATION BY RAYNER IDENTIFIED THAT THE ISSUE AFFECTED ALL UNITS IN THE RAYONE EMV RAO200E +19.0D BATCH 012183745 AND RAYONE EMV RAO200E +21.0 D BATCH 012183845. THE ACUTE CONSEQUENCE OF THE HEALTH HAZARD TO THE PATIENT IS A REFRACTIVE SURPRISE; A DEVIATION IN TARGET REFRACTION THAT COULD BE NOTICED BY THE PATIENT FOLLOWING SURGERY (MANIFESTING IN THIS CASE AS BLURRED DISTANCE VISION DUE TO THE MYOPIC REFRACTIVE ERROR) WHICH WOULD BE CONFIRMED WHEN THE PATIENT'S SURGICAL/OPTICAL TEAM DETERMINES THE PATIENT'S REFRACTION. THE MOST PROBABLE RESULT FOR PATIENTS WHO HAVE UNDERGONE IMPLANTATION OF A +21.0 D EMV LENS AS OPPOSED TO THE REQUIRED +19.0 D IS A 2.0 D MYOPIC OUTCOME. THE RAYONE EMV RAO200E +19.0D BATCH 012183745 IS SUBJECT TO A VOLUN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14461037 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.