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

Model Number SOFTECHDO+13.5

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Inflammation (1932); Intraocular Pressure Increased (1937); Pupillary Block (2026); Unspecified Eye / Vision Problem (4471); Insufficient Information (4580)

Event Date 03/30/2022

Event Type  Injury  

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 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.".

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 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
• Type of Device: 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
• MDR Text Key: 307259871
• Report Number: 9613160-2023-00001
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369037129
• UDI-Public: 00844369037129
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P090022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1