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

Model Number SOFTECI+18.5

Device Problems Contamination /Decontamination Problem (2895); Patient Device Interaction Problem (4001)

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

Event Date 08/18/2020

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.Microscopic examination of the lens indicated that the cloudiness seen was superficial, did not stain for calcium and did not extend through the matrix of the lens.Hence, we can find no evidence to suggest that there is any fault in the manufactured lens that would have brought rise to this opacification.Based on the review conducted on this case by lenstec' s medical monitor, it was concluded that any iol could potentially lose clarity in this intraocular environment created by the patient's ongoing medical conditions (diabetes and glaucoma).

Event Description

Lenstec received an email stating " dr.Noticed a frosted appearance on the lens and replaced with a competitors lens.".

• 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: 10541555
• MDR Text Key: 207207659
• Report Number: 9613160-2020-00061
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369029384
• UDI-Public: 00844369029384
• 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: 09/16/2020

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 Expiration Date: 03/14/2024
• Device Model Number: SOFTECI+18.5
• Device Catalogue Number: SOFTEC I
• Device Lot Number: 190318
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2019
• 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