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

Model Number SOFTECI+20.0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hyperemia (1904)

Event Date 06/10/2022

Event Type  Injury  

Manufacturer Narrative

A full audit of all batch documentation relating to the production of the device was performed.The audit concluded that all procedures in manufacturing and packaging of the device had been conducted correctly.Batch reconciliation was 100.0%.Lenstec can also confirm that there have never been any confirmed lens-related cases of conjunctival hyperemia of our hema lenses.

Event Description

Lenstec received an email stating " the patient had postoperative conjunctival hyperemia.The implant date was the (b)(6) 2022; there was no patient injury or surgical intervention noted and the lens remains implanted.Updated details received on 29 june 2022 stated the patient was treated with eye drops and is currently in good condition with no adverse reactions.".

• Brand Name: SOFTEC I
• 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: 15094206
• MDR Text Key: 296490308
• Report Number: 9613160-2022-00010
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369029445
• UDI-Public: 00844369029445
• 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
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SOFTECI+20.0
• Device Catalogue Number: SOFTEC I
• Device Lot Number: 204603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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