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

Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Conjunctivitis (1784)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lenstec is awaiting additional information, once received a supplemental report will be submitted.The lens remains implanted.
Event or Problem Description
Lenstec received an email stating "after surgery, the patient had symptoms of conjunctival congestion and yellowish white exudation".
Additional Manufacturer Narrative
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.The lens remains implanted.
Event or Problem Description
Lenstec received an email stating "after surgery, the patient had symptoms of conjunctival congestion and yellowish white exudation".

• Brand Name: SOFTEC I
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, BB170 92; BB BB17092
• Manufacturer (Section G): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, BB170 92; BB BB17092
• Manufacturer Contact: jimmy chacko ; 1765 commerce ave. n.; st. petersburg, FL 33716 ; 7275712272
• MDR Report Key: 21249183
• Report Number: 9613160-2025-00003
• Device Sequence Number: 8206155
• Product Code: HQL
• UDI-Device Identifier: 00844369029544
• UDI-Public: 00844369029544
• 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: 2024
• 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): 02/20/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DICLOFENAC SODIUM EYE DROPS; DICLOFENAC SODIUM EYE DROPS; LEVOFLOXACIN EYE DROPS; LEVOFLOXACIN EYE DROPS; SODIUM HYALURONATE EYE DROPS; SODIUM HYALURONATE EYE DROPS; TOBRAMYCIN DEXAMETHASONE EYE DROPS; TOBRAMYCIN DEXAMETHASONE EYE DROPS
• Patient Sex: Unknown