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

Model Number SOFTECI+21.5

Device Problem Device Handling Problem (3265)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/11/2020

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%.Based on the assessment of our batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Based on the investigation, lenstec concludes that the lens was handled incorrectly.

Event Description

Lenstec received an email stating " lens implanted (b)(6) 2020; explant date (b)(6) 2020.Lenstec received a form indicating 'broken haptic'.A back up lens was implanted and there was no patient injury or surgical intervention noted.

• 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: 11645265
• MDR Text Key: 260995684
• Report Number: 9613160-2021-00012
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369029506
• UDI-Public: 00844369029506
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2024
• Device Model Number: SOFTECI+21.5
• Device Catalogue Number: SOFTEC I
• Device Lot Number: SB06216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Date Manufacturer Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• 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