MAUDE Adverse Event Report: Lenstec Barbados Inc. Softec HD; Intraocular Lens

Lot Number	SB23697
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Eye Irritation (4803)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Lenstec received an email stating "orig "[sic]" surgery date on (b)(6) 2026 left eye softec hd +18.75 sn: (b)(6).First day post op on (b)(6) 2026, blurry vision left eye 20/400, 2 weeks post op left eye 20/200 blurry vision a shadow in left corner, eye feels after surgery irritated.Explant lens on (b)(6) 2026.Target goal now - 1.50 & new lens li61ao +16.00 sn: (b)(6).Patient had w/retinal tear w/o detachment surgery in the pass "[sic]", laser for retinal tear left eye, dry eye syndrome".
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.There was no evidence to suggest that any part of these processes caused the blurry vision experienced by the patient.Additionally, we have not received any other complaints from this batch.Based on the results of the investigation, the lens was returned in two pieces.Both pieces consisted of approximately half of the optic and one intact haptic.The cross sections were straight and smooth and appeared to be cut with a sharp object.The cut to the lens was probably to facilitate removal from the eye.The cross sections and the lens surface were clear and did not carry any cloudy / blurry appearances.The assessment by lenstec's vice president, clinical services stated that it appeared that the poor visual result was primarily due to des and residual myopia.Lenstec can confirm that our devices are 100% inspected at the final clean and inspection department and if any surface defects were present on the lens, it would not have been packed for shipping.Lenstec can also confirm 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 HD
• 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 ; +1(727)571-2272
• MDR Report Key: 50074331
• Report Number: 9613160-2026-00048
• Device Sequence Number: 16072344
• Product Code: HQL
• UDI-Device Identifier: 00844369027243
• UDI-Public: 00844369027243
• 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: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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: SB23697
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2025
• 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