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

Model Number	SOFTECHDO+13.5
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Intraocular Pressure Increased (1937); Pupillary Block (2026); Unspecified Eye / Vision Problem (4471); Insufficient Information (4580)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no evidence to suggest that any aspect of this device was responsible for the reported inflammation and an investigation is on-going.The device remains implanted.A supplemental report will be submitted once additional requested information is provided along with review from medical monitor.
Event or Problem Description
Lenstec received an email stating "the patient had diabetes and poor blood sugar control, the patient suddenly experienced eye swelling and pain, pupil closure and iop t+3 and decreased vision.Lens remains implanted and no reported patient injury.".
Additional Manufacturer Narrative
There is no evidence to suggest that any aspect of this device was responsible for the reported inflammation.The device remains implanted.The assessment of the medical monitor concluded there was no evidence to indicate the iol as the source of the reported incident.
Event or Problem Description
Lenstec received an email stating "the patient had diabetes and poor blood sugar control, the patient suddendly experienced eye swelling and pain, pupil closure and iop t+3 and decreased vision.Lens remains implanted and no reported patient injury.".

• Brand Name: SOFTEC HDO
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• Manufacturer (Section G): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• Manufacturer Contact: jimmy chacko ; 1765 commerce ave. n.; st. petersburg, FL 33716 ; 7275712272
• MDR Report Key: 16153022
• Report Number: 9613160-2023-00001
• Device Sequence Number: 7005531
• Product Code: HQL
• UDI-Device Identifier: 00844369037129
• UDI-Public: 00844369037129
• 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: 2022
• 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): 02/01/2023

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 Model Number: SOFTECHDO+13.5
• Device Catalogue Number: SOFTEC HDO
• Device Lot Number: 213805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2021
• 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