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

Model Number SOFTECHD+23.5

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

Patient Problem Intraocular Pressure Increased (1937)

Event Date 06/21/2022

Event Type  Injury  

Manufacturer Narrative

Based on the assessment of our batch documentation review, 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.There was no evidence to suggest that any aspect of this device was responsible for the reported anterior chamber fibrous exudation and increased intraocular pressure.Furthermore, the patient has recovered.The assessment by lenstec's medical monitor stated that since the anterior fibrosis has resolved, this suggests that the origin may have been systemic or ocular.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 received an email stating " anterior chamber fibrous exudation and increased intraocular pressure occured after the lens implantation in the left eye.".

• Brand Name: SOFTEC HD
• 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: 15611006
• MDR Text Key: 301819055
• Report Number: 9613160-2022-00017
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369027434
• UDI-Public: 00844369027434
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P090022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2022

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
• Device Operator: Health Professional
• Device Model Number: SOFTECHD+23.5
• Device Catalogue Number: SOFTEC HD
• Device Lot Number: 214459
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2021
• 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