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

Model Number SOFHDPLI+20.0D AND PLITIP1645 KIT

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problem Corneal Edema (1791)

Event Date 02/24/2021

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.

Event Description

Lenstec received an email stating " the lens was broken when doing the surgery, the broken lens was explanted and a new iol was implanted.Removal of the lens requires a larger incision and damages the patients corneal endothelium, the patients corneal edema persisted for 20 days after the surgery".Additional information provided stated that " the patient is recovering well now, no pharmaceuticals administered".

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%.Additionally, no other complaints have been received from this batch.The investigation of the device indicates that the damage on the lens was due to surgical manipulation and removal from the eye (lens was cut).Furthermore, all lenstec's devices are 100% inspected and if damages were present the device would have been rejected.Moreover, lenstec ensures though previous validations, that if the instruction for use are followed, the lens will be implanted without damage.

Event Description

Lenstec received an email stating " the lens was broken when doing the surgery, the broken lens was explanted and a new iol was implanted.Removal of the lens requires a larger incision and damages the patients corneal endothelium, the patients corneal edema persisted for 20 days after the surgery".Additional information provided stated that " the patient is recovering well now, no pharmaceuticals administered".

• Brand Name: SOFTEC HD PLI
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 11942113
• MDR Text Key: 260728955
• Report Number: 9613160-2021-00014
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369002516
• UDI-Public: 00844369002516
• Combination Product (y/n): N
• PMA/PMN Number: P090022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SOFHDPLI+20.0D AND PLITIP1645 KIT
• Device Catalogue Number: SOFTEC HD PLI
• Device Lot Number: SB10208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1