SOFTEC I SOFTECI+22.5Recalls & reported problems
Lenstec Barbados Inc · IOL - HEMA - 1pc 5.75/12.0mm · Class 3 · Implant
All models of SOFTEC I (26)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00844369029544), received between Jan 5, 2018 and Jan 27, 2025 — classified as 9 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, 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
- Adverse Event Without Identified Device or Use Problem5
- Insufficient Device Problem Information5
- Contamination3
- Device Contamination with Chemical or Other Material3
- Device Handling Problem2
Patient problems
- No Known Impact Or Consequence To Patient5
- Corneal Clouding/Hazing3
- Conjunctivitis1
- Deposits1
- No Code Available1
- No Consequences Or Impact To Patient1
- Toxic Anterior Segment Syndrome (TASS)1
- Unspecified Eye / Vision Problem1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING "AFTER SURGERY, THE PATIENT HAD SYMPTOMS OF CONJUNCTIVAL CONGESTION AND YELLOWISH WHITE EXUDATION".
Patient problems: Conjunctivitis
MAUDE report 21249183 ↗InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING " THE SURFACE OF SOFTEC I CRYSTAL APPEARS SIMILAR TO GROUND GLASS, WITH A LAYER OF WHITE MATERIAL ATTACHED. AFTER IMPLANTATION OF THE CRYSTAL, THE PATIENT APPEARS INFLAMMATION, AND THE INFLAMMATION IS SEVERE. TWO OR THREE DAYS AFTER THE OPERATION, THE WHITE MATERIAL ATTACHED TO THE CRYSTAL SURFACE DISAPPEARED, AND THE INFLAMMATION REMAINED. THE PHENOMENON OF CRYSTAL HAS APPEARED MANY TIMES".
Patient problems: Toxic Anterior Segment Syndrome (TASS); Unspecified Eye / Vision Problem
MAUDE report 11388720 ↗InjuryMay 14, 2020Device Handling Problem; Device Handling Problem
LENSTEC, INC. RECEIVED AN EMAIL NOTIFICATION STATING "TORN HAPTIC, WOUND ENLARGED. LENS REMOVED AND A NEW LENS INSERTED".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10059670 ↗InjuryAug 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
LENSTEC RECEIVED AN EMAIL STATING "CATARACT OP ON THE LEFT EYE WITHOUT COMPLICATIONS ON (B)(6) 2007, USE OF A MONOFOCAL IOL +22.5 DIOPTER. ON (B)(6) 2019 FINDING THAT IOL CLOUDED ON THE LEFT EYE, IOL EXCHANGE IS REQUIRED" THE LENS REMAINS IMPLANTED.
Patient problems: Deposits
MAUDE report 8916545 ↗InjuryJan 26, 2018Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem
LENSTEC RECEIVED NOTIFICATION OF A TORN HAPTIC, INCISION ENLARGED, LENS REMOVED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7223059 ↗InjuryJan 5, 2018Contamination; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Contamination; Device Contamination with Chemical or Other Material
IOL REPORTED TO BE "HAZY" UNDER SLIT LAMP AFTER OPERATION.
Patient problems: Corneal Clouding/Hazing; No Known Impact Or Consequence To Patient
MAUDE report 7169996 ↗InjuryJan 5, 2018Contamination; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Contamination; Device Contamination with Chemical or Other Material
IOL REPORTED TO BE "HAZY" UNDER SLIT LAMP AFTER OPERATION.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 7169993 ↗InjuryJan 5, 2018Contamination; Device Contamination with Chemical or Other Material; Insufficient Device Problem Information; Contamination; Device Contamination with Chemical or Other Material
IOL REPORTED TO BE "HAZY" UNDER SLIT LAMP AFTER OPERATION.
Patient problems: Corneal Clouding/Hazing; No Known Impact Or Consequence To Patient
MAUDE report 7169991 ↗InjuryJan 5, 2018Insufficient Device Problem Information
IOL REPORTED TO BE "HAZY" UNDER SLIT LAMP AFTER OPERATION.
Patient problems: Corneal Clouding/Hazing
MAUDE report 7169937 ↗
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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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