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

Model Number	SOFTECHDM+15.75
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Lenstec received an email notification stating 'explanted as patient was unhappy with the lens experiencing negative dysphotopsia'.
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%.Based on the assessment of our batch documentation and actual device analysis, lenstec believes that the lens, its design and the manufacturing process are not at fault due to extensive testing conducted on this model.

• Brand Name: SOFTEC HDM
• 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: 15212407
• Report Number: 9613160-2022-00011
• Device Sequence Number: 17298829
• Product Code: HQL
• UDI-Device Identifier: 00844369039130
• UDI-Public: 00844369039130
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2022

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: 08/11/2024
• Device Model Number: SOFTECHDM+15.75
• Device Catalogue Number: SOFTEC HDM
• Device Lot Number: S11040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2019
• 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