TECNIS IOL DXW150 (REF DXW150U220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474763012), received between Jun 13, 2023 and Mar 31, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING IMPLANTATION OF A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DXW150, IN THE PATIENT¿S LEFT EYE, THE PATIENT EXPERIENCED DECREASED CONTRAST SENSITIVITY AND INTOLERABLE POSTOPERATIVE GLARE. AS A RESULT, THE LENS WAS EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A PRELOADED MONOFOCAL INTRAOCULAR LENS (MODEL DCB0000215). THE PATIENT EXPERIENCED TEMPORARY VISUAL IMPAIRMENT AND REPORTED DIFFICULTY DRIVING AT NIGHT. BEST-CORRECTED VISUAL ACUITY WAS REPORTED AS 20/20 BOTH PREOPERATIVELY AND POSTOPERATIVELY. AT ONE WEEK FOLLOWING LENS REPLACEMENT, UNCORRECTED VISUAL ACUITY WAS REPORTED AS 20/30. THERE WERE NO INCISION ENLARGEMENTS, VITRECTOMY, SUTURES, PROCEDURAL DELAYS, OR MEDICATIONS REQUIRED OUTSIDE THE STANDARD OF CARE. THE DIRECTIONS FOR USE WERE REPORTED TO HAVE BEEN FOLLOWED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 24741977 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF A PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS, THE PATIENT EXPERIENCED EXCESSIVE LIGHTS, DYSPHOTOPSIA, AND GLARE. THE PATIENT WAS UNABLE TO PERFORM ACTIVITIES SHE COULD DO PRIOR TO THE IMPLANT AND WAS VERY DISTRESSED DUE TO HER INABILITY TO DRIVE AND READ CLEARLY. AS A RESULT, THE LENS WAS EXPLANTED DURING A SECONDARY SURGERY AND REPLACED WITH ANOTHER LENS. THERE WAS NO CAPSULE TEAR, AND NO REPORTS OF UNPLANNED VITRECTOMY OR SUTURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Visual Disturbances

  MAUDE report 23009668 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DXW150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT REPORTS CONCENTRIC CIRCLES AND STARBURSTS ARE SEEN WITH BRIGHT LIGHTS AND ALL LIGHTS BLUR TOGETHER AT NIGHT TIME. SYMPTOMS DO NOT OCCUR DURING THE DAY AND THE PATIENT CAN'T MAKE PLANS AFTER 4PM DUE TO VISUAL ISSUES. PILOCAR WAS PRESCRIBED AFTER THE LENSES WERE IMPLANTED AND PATIENT TAKES RESTASIS 2X A DAY FOR DRY EYE WHICH IS WORKING; PATIENT HAD DRY EYES PRIOR TO THE IOL IMPLANTS. SHE ALSO REPORTS WHEN HER EYES MOVE FROM SIDE TO SIDE IT FEELS LIKE THE LENS IS MOVING. PATIENT IS GETTING 2ND OPINION IN MAY. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Flashers; Halo

  MAUDE report 21627189 ↗
• InjuryOct 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PLANNED EXPLANT OF A TORIC INTRAOCULAR LENS (IOL) OF PATIENT'S LEFT EYE WAS REPORTED BECAUSE THE BAG SEEMED TO HAVE A PERIPHERAL EXTENSION/OPENING AND LENS LOOKED TILTED. THE LENS WAS EXPLANTED ON THE NEXT DAY AS THE DOCTOR BELIEVED THE BAG MAY BE INTACT. THE LENS REMOVAL WENT FINE, THE DOCTOR DID A VITRECTOMY TO BE SAFE AND THEN IMPLANTED A ZMA LENS AS A REPLACEMENT IOL. THE DOCTOR DID PLACE A SUTURE AT THE END OF THE PROCEDURE. THE LENS WAS NOT SAVED BY THE ACCOUNT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 20377112 ↗
• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED MULTIFOCAL INTRAOCULAR LENSES (IOLS) WERE IMPLANTED IN THE RIGHT AND LEFT EYE, THE PATIENT COULD NOT TOLERATE THE GLARE AND HALO AT NIGHT IN BOTH EYES. THE PATIENT'S SYMPTOMS STARTED SHORTLY AFTER THE INITIAL IMPLANT SURGERY FOR BOTH EYES, BUT SPECIFIC DATES ARE UNKNOWN.THE SURGEON MADE EVERY POSSIBLE ADJUSTMENT WITH GLASSES, DROPS, AND YTTRIUM ALUMINUM GARNET (YAG) LASER TO IMPROVE THE PATIENT¿S CONDITION. THE EYE DROPS GIVEN TO THE PATIENT WERE OUTSIDE OF THE STANDARD OF CARE, HOWEVER IT IS UNKNOWN WHAT DROPS WERE PROVIDED. THE DATE(S) OF THE YAG PROCEDURE AND WHICH EYE IT WAS PERFORMED ON IS UNKNOWN. THE SURGEON SENT THE PATIENT FOR A SECOND OPINION AND BOTH IOLS WERE EXCHANGED BY A DIFFERENT SURGEON FOR NON-JOHNSON AND JOHNSON MONOFOCAL IOLS. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT IS FULLY RECOVERED. THE LENSES WERE DISCARDED. ADDITIONAL INFORMATION WAS RECEIVED FROM A LETTER FROM THE PATIENT, REPORTING THAT THE MULTIFOCAL LENSES DID NOT YIELD THE EXPECTED RESULTS AND THE PATIENT EXPERIENCED SEVERE AND SIGNIFICANT HALOS AROUND LIGHT SOURCES AND DISCOMFORT, PARTICULARLY WHI

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18406645 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO "EVERYTHING WAS NOT PERFECT". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 17122586 ↗