MAUDE Adverse Event Report: LENSTEC BARBADOS INC. SOFTEC I; INTRAOCULAR LENS

Lot Number	234946
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Lenstec received an email stating ""haptic broke on insertion - iol destroyed.".
Additional Manufacturer Narrative
Based on the review of the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the device were conducted correctly.Additionally, we have not received any other complaints from this batch.As the device was not returned for inspection, lenstec was unable to perform a more detailed investigation into this complaint.We are therefore unable to conclude what may have taken place which would have caused the haptic to break during insertion.As such, we are unable to determine a specific cause for this incident.

• Brand Name: SOFTEC I
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commerical centre; pilgram road; christ church, BB170 92; BB BB17092
• Manufacturer (Section G): LENSTEC BARBADOS INC.; airport commerical centre; pilgram road; christ church, BB170 92; BB BB17092
• Manufacturer Contact: jimmy chacko ; 1765 commerce ave. n.; st. petersburg, FL 33716 ; 7275712272
• MDR Report Key: 22395984
• Report Number: 9613160-2025-00029
• Device Sequence Number: 14677905
• Product Code: HQL
• UDI-Device Identifier: 00844369029483
• UDI-Public: 00844369029483
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Lot Number: 234946
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 07/03/2025
• Date Device Manufactured: 01/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown