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

Model Number	SOFTECI+20.0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperemia (1904)
Date of Event	06/10/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: 15094206
• Report Number: 9613160-2022-00010
• Device Sequence Number: 12064101
• Product Code: HQL
• UDI-Device Identifier: 00844369029445
• UDI-Public: 00844369029445
• 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
• Report Date (Section B): 07/21/2022

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 Expiration Date: 12/07/2025
• Device Model Number: SOFTECI+20.0
• Device Catalogue Number: SOFTEC I
• Device Lot Number: 204603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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