enVista Envy™ IOL (REF ENU1900)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10757770637246), received between Apr 23, 2025 and Dec 23, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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.

Recalls naming this device

1. Mar 27, 2025Open, Classified

   In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.

   Z-1680-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE PATIENT PRESENTED WITH A MILD CENTRAL CAPSULAR WRINKLE AND CAPSULAR CONTRACTION WAS NOTED AT THE 5'CLOCK POSITION. THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) DID NOT DECREASE. APPROXIMATELY THREE MONTHS POST-IMPLANTATION, THE SURGEON PLANNED TO EXCHANGE THE IOL. HOWEVER, WHEN ATTEMPTING TO EXPLANT THE LENS, EXCESSIVE SCAR TISSUE AROUND THE IOL AND ZONULAR WEAKNESS WERE ENCOUNTERED. THE SURGEON ELECTED NOT TO REMOVE THE LENS AND LEFT THE IOL IN PLACE. THE SURGEON PLANS TO RE-EVALUATE THE PATIENT IN ONE MONTH BEFORE PROCEEDING WITH YAG LASER CAPSULOTOMY TREATMENT. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS THE LENS SHIFTING POSTERIORLY SECONDARY TO POSTOPERATIVE INFLAMMATION. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: PRED 1% OD BID, THEN TAPER MOXIFLOXACIN 0.5% 1GTT QID OU X 1 WEEK PROLENSA 0.07% 1GTT QD X 4 WEEKS.

  Patient problems: Capsular Contracture; Inflammation; Posterior Capsule Opacification; Zonular Dehiscence

  MAUDE report 23882226 ↗
• InjuryApr 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ONE DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE PATIENT PRESENTED WITH INCREASED AC INFLAMMATION WITH SOME FIBRIN, POSSIBLE TASS. SLIT LAMP FINDINGS WERE APPROXIMATELY 2+ C/F WITH FIBRIN IN AC. INTRAOCULAR INJECTION (VANCOMYCIN AND TOBRADEX) WERE ADMINISTERED ON THAT DAY. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS EITHER TASS OR INFECTIOUS ENDOPHTHALMITIS. THE PATIENT WAS LAST SEEN BY THE SURGEON APPROXIMATELY TWO MONTHS POST OP AND PATIENT'S OUTCOME IS GOOD. THEIR CHART STATES ¿ACUTE ENDOPHTHALMITIS RESOLVED¿.

  Patient problems: Endophthalmitis; Inflammation

  MAUDE report 21905072 ↗
• InjuryApr 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 1 DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE (OD), THE PATIENT PRESENTED WITH INCREASED ANTERIOR CHAMBER CELLS AND FIBROTIC WEB OVER IOL. BASED ON THE FINDINGS THE SURGEON CONCLUDED THE CAUSE AS TOXIC ANTERIOR SEGMENT SYNDROME (TASS). AN ANTERIOR CHAMBER WASHOUT WAS PERFORMED, AND AN INJECTION OF ACEF/VANCOMYCIN WAS ADMINISTERED. THE PATIENT'S BCVA DID NOT DECREASE. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS RELATED TO STORAGE MEDIA FOR IOL. PATIENT OUTCOME IS GOOD. THE FOLLOWING MEDICATIONS WERE PRESCRIBED (FOR USE AT HOME POST-OPERATIVELY): TOBRADEX 1 DROP EVERY HOUR, ZYMAXID 1 DROP EVERY HOUR, AVALOX 400 MG QD 1 WEEK.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 21893875 ↗