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

Lot Number	SB18160
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the review of the batch documentation conducted, 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.Due to the absence of the device, lenstec was unable to perform a more thorough investigation of this complaint.We are therefore unable to determine what may have taken place to cause the loop of the lens to be broken during the surgery.However, lenstec confirms that the lens, its design, and the manufacturing process are not at fault due to the extensive testing that we have performed on this model.Therefore, lenstec recommends that the user follow the instructions for use which indicates the procedure for correct implantation of the lens.
Event or Problem Description
Lenstec received an email stating ""the loop of the lens was broken during the surgery." the implant / explant date was (b)(6) 2024 and another lens was implanted.There was no patient injury or surgical intervention noted.The device was discarded at the facility.

• Brand Name: SOFTEC HD PLI
• 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
• MDR Report Key: 21941588
• Report Number: 9613160-2025-00013
• Device Sequence Number: 13041902
• Product Code: HQL
• UDI-Device Identifier: 00844369002615
• UDI-Public: 00844369002615
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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: SB18160
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2024
• 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