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

Lot Number	223229
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device reported remains implanted and therefore, not returned to lenstec.However, there is no evidence to suggest that any aspect of this device was responsible for the reported event.Additional assessment is ongoing, once completed a supplemental report will be submitted.
Event or Problem Description
Lenstec received an email stating "white membrane symptoms after surgery.".
Event or Problem Description
Lenstec received an email stating "white membrane symptoms after surgery.".
Additional Manufacturer Narrative
Based on the investigation lenstec confirms that there was no evidence to suggest that any aspect of this device was responsible for the reported incident.Furthermore, lenstec's medical monitor reviewed the case and considers that surgical factors are more likely the causative factor.Moreover, lenstec cannot comment on validity of the surgical sterilization practices of the user facility.Additionally, as the lens remains implanted lenstec is unable to conduct further analysis on the actual device.However, lenstec conducted additional device testing to iso 11979 and all were within limits.Furthermore, 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.

• 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: 20087792
• Report Number: 9613160-2024-00073
• Device Sequence Number: 20786044
• Product Code: HQL
• UDI-Device Identifier: 00844369037570
• UDI-Public: 00844369037570
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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 Lot Number: 223229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2022
• 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