EVO/EVO+VISIAN Implantable Collamer LensRecalls & reported problems across all models
Staar Surgical Company · 1,030 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
12 open recalls name at least one EVO/EVO+VISIAN Implantable Collamer Lens model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4,545
- Deaths reported
- 0
- Injuries reported
- 3,552
- Recalls
- 12
We found 1,030 models of EVO/EVO+VISIAN Implantable Collamer Lens by Staar Surgical Company in the FDA's device registry (GUDID). Together they are named in 4,545 adverse event reports in the FDA's MAUDE database, received between May 19, 2022 and Sep 30, 2026 — classified as 3,552 injuries, 993 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (701 reports).
12 FDA recall records name at least one of these models by its device identifier, 12 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. 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
EVO/EVO+VISIAN Implantable Collamer Lens recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 21, 2026Class IIOpen, Classified
Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal.
Z-1480-2026 · Root cause: Process control · Recall details · FDA record ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential that intraocular implant devices may not meet specifications.
Z-0474-2024 · Root cause: Software design (manufacturing process) · names 4 of these models · Recall details · FDA record ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential that intraocular implant devices may not meet specifications.
Z-0473-2024 · Root cause: Software design (manufacturing process) · names 6 of these models · Recall details · FDA record ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential that intraocular implant devices may not meet specifications.
Z-0472-2024 · Root cause: Software design (manufacturing process) · names 11 of these models · Recall details · FDA record ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential that intraocular implant devices may not meet specifications.
Z-0471-2024 · Root cause: Software design (manufacturing process) · names 14 of these models · Recall details · FDA record ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential that intraocular implant devices may not meet specifications.
Z-0470-2024 · Root cause: Software design (manufacturing process) · names 3 of these models · Recall details · FDA record ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential that intraocular implant devices may not meet specifications.
Z-0469-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential that intraocular implant devices may not meet specifications.
Z-0468-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential that intraocular implant devices may not meet specifications.
Z-0467-2024 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential that intraocular implant devices may not meet specifications.
Z-0466-2024 · Root cause: Software design (manufacturing process) · names 13 of these models · Recall details · FDA record ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential that intraocular implant devices may not meet specifications.
Z-0465-2024 · Root cause: Software design (manufacturing process) · names 19 of these models · Recall details · FDA record ↗
- Sep 29, 2023Class IIOpen, Classified
Their is a potential that intraocular implant devices may not meet specifications.
Z-0464-2024 · Root cause: Software design (manufacturing process) · names 9 of these models · Recall details · FDA record ↗
Most reported EVO/EVO+VISIAN Implantable Collamer Lens problems
Device problems
- Adverse Event Without Identified Device or Use Problem2,771
- No Apparent Adverse Event884
- Inadequacy of Device Shape and/or Size701
- Misfocusing203
- Device Dislodged or Dislocated154
- Off-Label Use141
- Unintended Movement89
- Optical Problem76
Patient problems
- No Clinical Signs, Symptoms or Conditions2,593
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available929
- Blurred Vision717
- Intraocular Pressure Increased245
- Visual Disturbances149
- Halo134
- Toxic Anterior Segment Syndrome (TASS)126
- Inflammation63
EVO/EVO+VISIAN Implantable Collamer Lens models
1,030 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-8.0)Lens, Intraocular, Phakic1 recall12 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-5.5)Lens, Intraocular, Phakic1 recall11 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-8.5)Lens, Intraocular, Phakic1 recall11 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-11.0)Lens, Intraocular, Phakic1 recall11 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-8.0)Lens, Intraocular, Phakic1 recall9 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-9.0)Lens, Intraocular, Phakic1 recall9 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-9.0)Lens, Intraocular, Phakic1 recall9 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-9.5)Lens, Intraocular, Phakic1 recall8 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-9.5)Lens, Intraocular, Phakic1 recall8 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-10.0)Lens, Intraocular, Phakic1 recall7 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-10.5)Lens, Intraocular, Phakic1 recall7 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-12.0)Lens, Intraocular, Phakic1 recall7 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-11.5)Lens, Intraocular, Phakic1 recall7 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-12.0)Lens, Intraocular, Phakic1 recall7 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-6.5)Lens, Intraocular, Phakic1 recall6 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-6.5)Lens, Intraocular, Phakic1 recall6 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-5.0)Lens, Intraocular, Phakic1 recall5 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-6.0)Lens, Intraocular, Phakic1 recall5 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-7.0)Lens, Intraocular, Phakic1 recall5 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-7.5)Lens, Intraocular, Phakic1 recall5 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-8.5)Lens, Intraocular, Phakic1 recall5 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-11.0)Lens, Intraocular, Phakic1 recall5 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-11.5)Lens, Intraocular, Phakic1 recall5 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-5.0)Lens, Intraocular, Phakic1 recall5 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-7.5)Lens, Intraocular, Phakic1 recall5 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-10.5)Lens, Intraocular, Phakic1 recall5 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-12.5)Lens, Intraocular, Phakic1 recall5 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.1 (-5.0/1.0)Phakic Toric Intraocular Lens1 recall4 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-8.5/2.0)Phakic Toric Intraocular Lens1 recall4 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-13.5/1.5)Phakic Toric Intraocular Lens1 recall4 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-13.0/1.0)Phakic Toric Intraocular Lens1 recall4 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICMO 12.6 (-16.0)Lens, Intraocular, Phakic1 recall4 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICMO 13.2 (-15.0)Lens, Intraocular, Phakic1 recall4 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-5.5/1.5)Phakic Toric Intraocular Lens1 recall3 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-7.5/1.0)Phakic Toric Intraocular Lens1 recall3 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-11.5/2.5)Phakic Toric Intraocular Lens1 recall3 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-14.0/2.0)Phakic Toric Intraocular Lens1 recall3 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-7.0/1.0)Phakic Toric Intraocular Lens1 recall3 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-7.0/1.5)Phakic Toric Intraocular Lens1 recall3 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-11.0/3.5)Phakic Toric Intraocular Lens1 recall3 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.1 (-8.0)Lens, Intraocular, Phakic1 recall3 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.1 (-8.5)Lens, Intraocular, Phakic1 recall3 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-5.5)Lens, Intraocular, Phakic1 recall3 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-9.5/4.0)Phakic Toric Intraocular Lens1 recall2 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-12.0/1.0)Phakic Toric Intraocular Lens1 recall2 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-13.0/1.0)Phakic Toric Intraocular Lens1 recall2 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-13.5/3.5)Phakic Toric Intraocular Lens1 recall2 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.7 (-11.0/3.5)Phakic Toric Intraocular Lens1 recall2 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-13.0)Lens, Intraocular, Phakic1 recall2 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-13.5)Lens, Intraocular, Phakic1 recall2 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICMO 12.6 (-14.5)Lens, Intraocular, Phakic1 recall2 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICMO 12.6 (-15.0)Lens, Intraocular, Phakic1 recall2 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICMO 12.6 (-15.5)Lens, Intraocular, Phakic1 recall2 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.1 (-13.5/3.5)Phakic Toric Intraocular Lens1 recall1 report
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-4.0/2.0)Phakic Toric Intraocular Lens1 recall1 report
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-6.5/4.0)Phakic Toric Intraocular Lens1 recall1 report
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-10.0/2.0)Phakic Toric Intraocular Lens1 recall1 report
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-5.0/4.0)Phakic Toric Intraocular Lens1 recall1 report
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-8.0/1.0)Phakic Toric Intraocular Lens1 recall1 report
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-8.0/1.5)Phakic Toric Intraocular Lens1 recall1 report
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.7 (-9.5/2.5)Phakic Toric Intraocular Lens1 recall1 report
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.1 (-7.0)Lens, Intraocular, Phakic1 recall1 report
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.1 (-9.0)Lens, Intraocular, Phakic1 recall1 report
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.1 (-10.0)Lens, Intraocular, Phakic1 recall1 report
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.1 (-11.0)Lens, Intraocular, Phakic1 recall1 report
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-12.5)Lens, Intraocular, Phakic1 recall1 report
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-14.0)Lens, Intraocular, Phakic1 recall1 report
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.1 (-12.5/1.0)Phakic Toric Intraocular Lens1 recall0 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.1 (-13.0/2.5)Phakic Toric Intraocular Lens1 recall0 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 12.6 (-14.0/1.5)Phakic Toric Intraocular Lens1 recall0 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-4.0/1.0)Phakic Toric Intraocular Lens1 recall0 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-6.0/3.0)Phakic Toric Intraocular Lens1 recall0 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-8.5/3.5)Phakic Toric Intraocular Lens1 recall0 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.2 (-9.5/2.5)Phakic Toric Intraocular Lens1 recall0 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.7 (-10.5/4.0)Phakic Toric Intraocular Lens1 recall0 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.7 (-11.0/1.5)Phakic Toric Intraocular Lens1 recall0 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.7 (-11.0/2.0)Phakic Toric Intraocular Lens1 recall0 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VTICM5 13.7 (-13.0/3.0)Phakic Toric Intraocular Lens1 recall0 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.1 (-6.0)Lens, Intraocular, Phakic1 recall0 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.1 (-10.5)Lens, Intraocular, Phakic1 recall0 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.1 (-14.0)Lens, Intraocular, Phakic1 recall0 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.7 (-12.5)Lens, Intraocular, Phakic1 recall0 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICMO 12.1 (-14.5)Lens, Intraocular, Phakic1 recall0 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-8.5)Lens, Intraocular, Phakic49 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-10.0)Lens, Intraocular, Phakic41 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-9.0)Lens, Intraocular, Phakic39 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-7.5)Lens, Intraocular, Phakic37 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-9.5)Lens, Intraocular, Phakic34 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-9.0)Lens, Intraocular, Phakic32 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-6.5)Lens, Intraocular, Phakic31 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-8.0)Lens, Intraocular, Phakic31 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-8.0)Lens, Intraocular, Phakic31 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-9.5)Lens, Intraocular, Phakic31 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-10.5)Lens, Intraocular, Phakic30 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-8.5)Lens, Intraocular, Phakic30 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-7.0)Lens, Intraocular, Phakic28 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-10.0)Lens, Intraocular, Phakic28 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2 (-7.5)Lens, Intraocular, Phakic26 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-4.5)Lens, Intraocular, Phakic25 reports
- EVO/EVO+VISIAN Implantable Collamer Lens VICM5 12.6 (-5.5)Lens, Intraocular, Phakic25 reports
Recent EVO/EVO+VISIAN Implantable Collamer Lens adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50955035 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Visual Disturbances
MAUDE report 50953107 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Visual Disturbances
MAUDE report 50953106 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Blurred Vision
MAUDE report 50952558 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951612 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951292 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
A Facility representative reported that following an implantable collamer lens (ICL) implantation procedure, the patient experienced lens rotation. Lens was repositioned but that did not resolve the problem. In a separate surgery the lens was exchanged with a different power and the problem was resolved. The cause of the event was reported as a patient related factor. There are multiple medical device reports associated with this patient. This report is 1 of 2 total reports. Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950922 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50941073 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Blurred Vision
MAUDE report 50940917 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
A facility representative reported that following an implantable collamer lens (ICL) implantation procedure, the patient experienced excessive vault with significant reduction of iridocorneal angles and significant shallowing of the AC, cloudy vision and refractive surprise. Lens was exchanged for a shorter length lens and problem was resolved. Cause of the event was reported as unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937370 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50935591 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Intraocular Pressure Increased
MAUDE report 50926641 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Intraocular Pressure Increased
MAUDE report 50926640 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Cataract
MAUDE report 50926458 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926457 ↗
Other Staar Surgical Company products
All Staar Surgical Company devices →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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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