TECNIS IOL DXW300 (REF DXW300U150)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TEC SYMF TOR II OB SMPCY 15.0D CYL3.00 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474765238), received between Nov 10, 2023 and Nov 10, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2023Break; Failure to Advance; Break; Failure to Advance
IT WAS REPORTED THE PRELOADED JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) HAD A BENT HAPTIC. THE ISSUE WAS OBSERVED DURING LOADING/PRIMING OF THE LENS. DURING PRELOADING OF THE LENS THE DOCTOR NOTICED THE IOL DID NOT ADVANCE AS EASILY AS USUAL AND LOOKED CLOSER AND NOTICED THE HAPTICS WERE BENT. IN THE SURGEON¿S OPINION, THE PRODUCT CAUSED OR CONTRIBUTE TO THE EVENT. THERE WAS NO PATIENT CONTACT. THE ORIGINALLY SCHEDULED PROCEDURE WAS COMPLETED ON THE SAME DAY WITH A JNJ LENS OF THE SAME MODEL AND DIOPTER. THE CUSTOMER ALSO EXPLAINED THEY USED OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WHICH THEY ALLOWED TO ACCLIMATIZE FULLY TO THE TEMPERATURE IN THE OPERATING ROOM. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18108440 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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