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

Lot Number	161319
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	Macular Edema (1822); Retinal Detachment (2047); Retinal Tear (2050); Visual Disturbances (2140); Posterior Capsule Opacification (4807)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
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 and we have not received any other similar complaints from this batch.As the device remains implanted, lenstec was unable to perform a more thorough investigation into this complaint.Additionally, 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.Lenstec can also confirm that we have never had any confirmed lens-related cases of clouding, discolouration or opacification for our hema lenses.The assessment of the case by lenstec's medical monitor states the most likely explanation of the event was the long acting intraocular gas treatment for the retinal detachment along with the inferior haptic location misalignment.
Event or Problem Description
Lenstec inc.Received an e-mail stating that "the doctor saw a patient who is several years post op with an hdo.She has developed diffuse crystalline deposits deep inside the lens optic.The doctor noted that the opacities are patchy with some clear areas.Her vision is 20/20 but she has significant glare symptoms.He told the patient that the risks currently outweigh the benefits of removing the lens at this time unless the symptoms worsen.The patient agreed.".

• Brand Name: SOFTEC HDO
• 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: 22755026
• Report Number: 9613160-2025-00035
• Device Sequence Number: 18560134
• Product Code: HQL
• UDI-Device Identifier: 00844369037174
• UDI-Public: 00844369037174
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/03/2021
• Device Lot Number: 161319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2016
• 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