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

Model Number	SOFHDPLI+21.5D and PLITIP1645 Kit
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/23/2021
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%.The lens was discarded at the facility therefore was not able to be evaluated, however the retention sample from the identified batch was evaluated and no creases, marks or spots were noted on the device after injection.Lenstec confirms that the lens, its design, and the manufacturing process are not at fault due to the extensive testing performed on the model.All lenses are 100% inspected at final clean and found no defects.
Event or Problem Description
Lenstec received an email stating "the patient implanted the lens on (b)(6) 2021 and found annular spots in the center of the lens under the microscope.The doctor expanded the incision, took out the lens and replaced another lens implant.The foreign body sensation in the eye was aggravated after operation.The problem lens has been cut and discarded by the hospital".

• Brand Name: SOFTEC HD PLI
• 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: 14147495
• Report Number: 9613160-2022-00006
• Device Sequence Number: 17625490
• Product Code: HQL
• UDI-Device Identifier: 00844369002578
• UDI-Public: 00844369002578
• 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: 2021
• Device Explanted Year: 2021
• 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): 04/19/2022

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: 03/21/2026
• Device Model Number: SOFHDPLI+21.5D and PLITIP1645 Kit
• Device Catalogue Number: SOFTEC HD PLI
• Device Lot Number: 210749
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• 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