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

Catalog Number	102058447
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Conjunctivitis (1784); Inflammation (1932); Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Lenstec received an email stating: "the patient developed tass after the lens was implanted.Implantation date: (b)(6) 2025.Re-examination on (b)(6): the patient's blood routine test showed abnormalities, with elevated white blood cells and decreased hemoglobin, suggesting anterior segment toxic syndrome.The patient was re-examined and treated in the infectious disease and hematology departments.Administered cefuroxime for anterior chamber irrigation.Pranoprofen eye drops, tobramycin dexamethasone eye drops, and levofloxacin eye drops were instilled for local anti-inflammatory and anti-infection treatment, as well as mydriasis and other symptomatic treatments.Re-examination on (b)(6): right eye visual acuity 0.4, intraocular pressure 13 mmhg; mild conjunctival congestion, round pupil, aqueous flare+, exudative membrane visible in the pupil area, intraocular lens in place, fundus examination unclear.Continued cefuroxime for anterior chamber irrigation.Re-examination on (b)(6): mild conjunctival congestion in the right eye; right cornea transparent; right anterior chamber aqueous flare+, posterior synechia at the iris and pupil margin; right pupil dilated, d=6mm, exudative membrane visible in the pupil area, light reflex absent.Visual acuity hand motion, intraocular pressure 18 mmhg.Admitted for endophthalmitis treatment.Administered atropine sulfate eye gel for mydriasis, pranoprofen eye drops, gatifloxacin eye gel, tobramycin dexamethasone eye drops, and levofloxacin eye drops for local anti-inflammatory and anti-infection treatment, intravenous cefotaxime for systemic anti-infection treatment, and oral prednisone acetate tablets for anti-inflammatory and other symptomatic treatments.Patient injury noted.
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.There was no evidence to suggest that any aspect of this device was responsible for the reported incident.Additionally, the endotoxin results were within acceptable limits and we have not received any other complaints from this batch.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.Investigation ongoing.Once the device is received and inspected a supplemental report will be issued.
Additional Manufacturer Narrative
Based on the initial report (documentation analysis, endotoxin check results and complaint history) and the assessment by lenstec's medical monitor, lenstec concludes that there was no evidence to suggest that any aspect of this device was responsible for the reported incident.The assessment by lenstec's medical monitor stated that non-iol causes of inflammation/infection, as well as dozens of potential surgical steps could lead to an identical situation.Furthermore, lenstec cannot comment on the injector used.Lenstec also 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.
Event or Problem Description
Lenstec received an email stating : "the patient developed tass after the lens was implanted.".

• 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: 23888397
• Report Number: 9613160-2025-00060
• Device Sequence Number: 11938775
• Product Code: HQL
• UDI-Device Identifier: 00844369037297
• UDI-Public: 00844369037297
• 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
• 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): 01/16/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 102058447
• Device Lot Number: 251425
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ATROPINE SULFATE EYE GEL; ATROPINE SULFATE EYE GEL.; CEFOTAXIME; CEFOTAXIME.; CEFUROXIMEPRANOPROFEN TOBRAMYCIN DEXAMETHASONE.; CEFUROXIMEPRANOPROFEN TOBRAMYCIN DEXAMETHASONE.; GATIFLOXACIN EYE GEL; GATIFLOXACIN EYE GEL.; LEVOFLOXACIN EYE DROPS.; LEVOFLOXACIN EYE DROPS.; ORAL PREDNISONE ACETATE TABLETS.; ORAL PREDNISONE ACETATE TABLETS.; PRANOPROFEN EYE DROPS.; PRANOPROFEN EYE DROPS.; TOBRAMYCIN DEXAMETHASONE EYE DROPS.; TOBRAMYCIN DEXAMETHASONE EYE DROPS.
• Patient Sex: Unknown