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

Lot Number SB16373

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

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 08/02/2023

Event Type  Injury  

Manufacturer Narrative

Based on the review of the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the device were conducted correctly.Additionally, we have not received any other complaints from this batch.As the device was discarded, lenstec was unable to perform an inspection of the complaint device.However, lenstec confirms that the lens, its design, and the manufacturing process are not at fault due to the extensive testing that we have performed on this model.

Event Description

Lenstec, inc.Received an email notification stating "torn haptic per surgeon".

• Brand Name: SOFTEC HD
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, BB170 92,; BB BB17092,
• 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: 17627501
• MDR Text Key: 322022428
• Report Number: 9613160-2023-00016
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369027304
• UDI-Public: 00844369027304
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2023

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 Lot Number: SB16373
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2023
• 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