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

Model Number SOFTECI+13.5

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Capsular Contracture (1761)

Event Date 09/19/2022

Event Type  Injury  

Manufacturer Narrative

Lenstec is awaiting the arrival of the actual device to perform a comprehensive investigation.Once the investigation is complete a supplemental report will be submitted.

Event Description

Lenstec received an email stating " explanted due to significant capsular phimosis.The incision was enlarged with no patient injury.Another lens was implanted.".

Event Description

Lenstec received an email stating " explanted due to significant capsular phimosis.The incision was enlarged with no patient injury.Another lens was implanted.".

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 and the inspection revealed that the lens was intact; no damages or defects were noted.Capsular phimosis is a case of anterior capsular contraction syndrome (accs), usually related to the remnants of fibrous tissues that causes the anterior capsule to contract.Furthermore, 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.

• 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: 15642388
• MDR Text Key: 302121732
• Report Number: 9613160-2022-00018
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369029230
• UDI-Public: 00844369029230
• 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,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SOFTECI+13.5
• Device Catalogue Number: SOFTEC I
• Device Lot Number: 203800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2020
• 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