IC-8 Apthera IOLRecalls & reported problems across all models
Bausch & Lomb Incorporated · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls
- 0
We found 20 models of IC-8 Apthera IOL by Bausch & Lomb Incorporated in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between May 19, 2023 and Aug 18, 2026 — classified as 38 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).
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
Reports received per month, all models
Most reported IC-8 Apthera IOL problems
Device problems
- Adverse Event Without Identified Device or Use Problem25
- Insufficient Device Problem Information5
- Break4
- Device Dislodged or Dislocated2
- Dent in Material1
- Material Discolored1
- Material Opacification1
- Material Split, Cut or Torn1
Patient problems
- Visual Disturbances12
- Insufficient Information9
- Blurred Vision8
- Halo6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Visual Impairment5
- Diplopia/Double Vision4
- No Clinical Signs, Symptoms or Conditions3
IC-8 Apthera IOL models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- IC-8 Apthera IOL +23.0 DExtended Depth Of Focus Intraocular Lens5 reports
- IC-8 Apthera IOL +22.0 DExtended Depth Of Focus Intraocular Lens4 reports
- IC-8 Apthera IOL +22.5 DExtended Depth Of Focus Intraocular Lens4 reports
- IC-8 Apthera IOL +19.0 DExtended Depth Of Focus Intraocular Lens3 reports
- IC-8 Apthera IOL +24.0 DExtended Depth Of Focus Intraocular Lens3 reports
- IC-8 Apthera IOL +18.0 DExtended Depth Of Focus Intraocular Lens2 reports
- IC-8 Apthera IOL +25.0 DExtended Depth Of Focus Intraocular Lens2 reports
- IC-8 Apthera IOL +27.0 DExtended Depth Of Focus Intraocular Lens2 reports
- IC-8 Apthera IOL +29.5 DExtended Depth Of Focus Intraocular Lens2 reports
- IC-8 Apthera IOL +12.0 DExtended Depth Of Focus Intraocular Lens1 report
- IC-8 Apthera IOL +13.0 DExtended Depth Of Focus Intraocular Lens1 report
- IC-8 Apthera IOL +13.5 DExtended Depth Of Focus Intraocular Lens1 report
- IC-8 Apthera IOL +16.5 DExtended Depth Of Focus Intraocular Lens1 report
- IC-8 Apthera IOL +17.5 DExtended Depth Of Focus Intraocular Lens1 report
- IC-8 Apthera IOL +20.5 DExtended Depth Of Focus Intraocular Lens1 report
- IC-8 Apthera IOL +21.0 DExtended Depth Of Focus Intraocular Lens1 report
- IC-8 Apthera IOL +24.5 DExtended Depth Of Focus Intraocular Lens1 report
- IC-8 Apthera IOL +25.5 DExtended Depth Of Focus Intraocular Lens1 report
- IC-8 Apthera IOL +26.5 DExtended Depth Of Focus Intraocular Lens1 report
- IC-8 Apthera IOL +29.0 DExtended Depth Of Focus Intraocular Lens1 report
Recent IC-8 Apthera IOL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported that approximately 7 weeks after implantation of an intraocular lens (IOL), the lens was explanted and replaced with a monofocal due to unresolved blurry vision and halos. Additional information regarding this event was requested but not received.
Patient problems: Blurred Vision; Halo
MAUDE report 50308365 ↗InjuryMay 5, 2026Dent in Material
IT WAS REPORTED THAT APPROXIMATELY 3.5 MONTHS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE (OS), THE PATIENT COMPLAINED OF DISSATISFACTION WITH VISUAL CLARITY, DESCRIBING HALOS AND A SENSATION OF LOOKING THROUGH "DIRTY GLASS". APPROXIMATELY 6 MONTHS AFTER SYMPTOM ONSET, AN OPTOMETRIST OBSERVED A DIVOT IN THE SUPERIOR/TEMPORAL PORTION OF THE FILTER RING OF THE IOL'S OPTIC. APPROXIMATELY ONE YEAR LATER, THE INITIAL IOL WAS REMOVED AND A REPLACED WITH A DIFFERENT MODEL LENS POSITIONED IN THE SULCUS. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS THE PATIENT'S INABILITY TO ADAPT TO THE UNIQUE OPTICS OF THE IOL AND EXPERIENCED SUBJECTIVE VISUAL DISTURBANCES. PATIENT OUTCOME IS GOOD.
Patient problems: Halo; Visual Disturbances; Visual Impairment
MAUDE report 25084818 ↗InjuryDec 22, 2025Material Discolored; Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Material Discolored; Product Quality Problem; Adverse Event Without Identified Device or Use Problem
T WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENTS EYE DUE TO BLURRED VISION WITH A PURPLE HUE. CENTRAL POSTERIOR STREAKS WERE ALSO VISIBLE ON THE LENS. A SECOND IOL OF A DIFFERENT LENS MODEL AND POWER WERE IMPLANTED SUCCESSFULLY. THE SURGEON INDICATED THE CAUSE OF THE EVENT WAS POSSIBLY THE DELIVERY DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.
Patient problems: Visual Disturbances
MAUDE report 23863259 ↗InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT 2 DAYS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS), THE PATIENT WAS HAPPY WITH THEIR VISUAL ACUITY BUT EXPERIENCED GHOST IMAGES. APPROXIMATELY 3 MONTHS AFTER THE ONSET OF THE PROBLEM, THE LENS WAS EXCHANGED FOR A DIFFERENT MODEL IOL DUE TO UNRESOLVED GHOST IMAGES. PATIENT OUTCOME IS GOOD, GHOST IMAGES HAVE RESOLVED.
Patient problems: Visual Disturbances
MAUDE report 23542421 ↗InjuryOct 17, 2025Break; Unintended Movement; Break; Unintended Movement
IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE IOL TRAILING HAPTIC WAS ALLEGEDLY STUCK IN THE INJECTOR. THE FOLLOWING DAY, THE SURGEON OBSERVED THAT THE IOL WAS DECENTERED. APPROXIMATELY, 2 WEEKS LATER, AN IOL EXCHANGE WAS PERFORMED, AND IT WAS NOTED THAT THERE WAS A BROKEN HAPTIC ON THE INITIAL IOL. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS THE BROKEN HAPTIC. PATIENT OUTCOME IS GOOD.
Patient problems: Visual Impairment
MAUDE report 23323417 ↗InjurySep 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS), THE PATIENT DEVELOPED CAPSULAR CONTRACTION. APPROXIMATELY ONE MONTH AFTER IMPLANTATION OF THE IOL, THE PATIENT COMPLAINED OF A BROWN OR HAZY MIST, STATING IT WAS LIKE LOOKING THROUGH A CURTAIN. THE PATIENT REPORTED NOTICING A DECREASE IN VISION, BUT VISUAL ACUITY DID NOT DECREASE. THE SURGEON OBSERVED THE LENS TO BE DE-CENTERED NASALLY. APPROXIMATELY TWO WEEKS LATER, THE LENS WAS REPOSITIONED, AND A CAPSULAR TENSION RING WAS IMPLANTED. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS UNKNOWN AND IS CONSIDERING EXCHANGING THE IOL DUE TO UNRESOLVED HAZE. THE PATIENT REMAINS UNDER THE SURGEON'S CARE AND IS SCHEDULED TO BE SEEN AGAIN IN THE BEGINNING OF 2026.
Patient problems: Capsular Contracture; Visual Disturbances
MAUDE report 23014495 ↗InjuryAug 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ADDITIONAL INFORMATION WAS RECEIVED WITH THE SURGEON INDICATING NO ISSUES WITH THE IOL. LENS EXCHANGE WAS PERFORMED TWO WEEKS AFTER THE ORIGINAL IMPLANT DUE TO VISION ISSUES SUCH AS NOT SEEING WELL, VERY DIM AND LOOKING THROUGH A KEYHOLE.
Patient problems: Insufficient Information
MAUDE report 22841449 ↗InjuryAug 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ADDITIONAL INFORMATION WAS RECEIVED WITH THE SURGEON INDICATING NO ISSUES WITH THE IOL. LENS EXCHANGE WAS PERFORMED TWO WEEKS AFTER THE ORIGINAL IMPLANT DUE TO VISION ISSUES SUCH AS NOT SEEING WELL, VERY DIM AND LOOKING THROUGH A KEYHOLE.
Patient problems: Insufficient Information
MAUDE report 22840916 ↗InjuryAug 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ADDITIONAL INFORMATION WAS RECEIVED WITH THE SURGEON INDICATING NO ISSUES WITH THE IOL. LENS EXCHANGE WAS PERFORMED TWO WEEKS AFTER THE ORIGINAL IMPLANT DUE TO VISION ISSUES SUCH AS NOT SEEING WELL, VERY DIM AND LOOKING THROUGH A KEYHOLE.
Patient problems: Insufficient Information
MAUDE report 22819197 ↗InjuryAug 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ADDITIONAL INFORMATION WAS RECEIVED WITH THE SURGEON INDICATING NO ISSUES WITH THE IOL. LENS EXCHANGE WAS PERFORMED TWO WEEKS AFTER THE ORIGINAL IMPLANT DUE TO VISION ISSUES SUCH AS NOT SEEING WELL, VERY DIM AND LOOKING THROUGH A KEYHOLE.
Patient problems: Insufficient Information
MAUDE report 22819092 ↗InjuryAug 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ADDITIONAL INFORMATION WAS RECEIVED WITH THE SURGEON INDICATING NO ISSUES WITH THE IOL. LENS EXCHANGE WAS PERFORMED TWO WEEKS AFTER THE ORIGINAL IMPLANT DUE TO VISION ISSUES SUCH AS NOT SEEING WELL, VERY DIM AND LOOKING THROUGH A KEYHOLE.
Patient problems: Insufficient Information
MAUDE report 22819081 ↗InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY A YEAR AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE IOL WAS EXCHANGED WITH A DIFFERENT MODEL LENS DUE TO THE PATIENT COMPLAINING THAT VISION WAS TOO DARK. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22282470 ↗InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT APPROXIMATELY FIVE MONTHS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE PATIENTS LEFT EYE (OS), THE IOL WAS EXCHANGED WITH A DIFFERENT MODEL LENS DUE TO THE PATIENT EXPERIENCING VISUAL DYSPHOTOPSIAS IN LOW LIGHT CONDITIONS. THE POST EXCHANGE OUTCOME FOR THIS PATIENT IS REPORTED AS GOOD. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Visual Disturbances
MAUDE report 22106029 ↗InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS), THE IOL WAS EXPLANTED DUE TO PATIENT BEING INTOLERANT TO THE LENS. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: Insufficient Information
MAUDE report 21894729 ↗InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED INDICATING A DIFFERENT MODEL INTRAOCULAR LENS(IOL) WAS IMPLANTED IN THE PATIENT¿S FELLOW EYE ON THE SAME DATE. SINCE THE EXCHANGE PATIENT OUTCOME IS REPORTEDLY GOOD.
Patient problems: Insufficient Information; Visual Disturbances
MAUDE report 21583536 ↗
Other Bausch & Lomb Incorporated products
- enVista IOL74 models · 70 reports · 1 recall
- enVista Toric IOL450 models · 15 reports · 2 recalls
- enVista Envy IOL53 models · 52 reports · 1 recall
- enVista Envy Toric IOL513 models · 39 reports · 1 recall
- Akreos IOL8 models · 10 reports · 1 recall
- enVista Aspire IOL57 models · 10 reports · 1 recall
- enVista Aspire Toric IOL513 models · 8 reports · 1 recall
- SofPort IOL20 models · 29 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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