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

Model Number SOFTECHD+21.25

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 03/20/2023

Event Type  Injury  

Manufacturer Narrative

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.Additionally, we have not received any other complaints from this batch.We can find no evidence to suggest that there is any fault in the manufactured lens that would have brought rise to this cloudiness.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.Lenstec can also confirm that we have never had any confirmed lens-related cases of clouding, discolouration or opacification for our hema lenses.Lenstec is currently awaiting information from the implanting and explanting doctors and will provide a supplemental report on completion of our investigation.

Event Description

Lenstec received an email stating " lens is calcified-explanted.There was no patient injury and another lens was implanted.".

Event Description

Lenstec received an email stating " lens is calcified-explanted.There was no patient injury and another lens was implanted.".

Manufacturer Narrative

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.Additionally, we have not received any other complaints from this batch.We can find no evidence to suggest that there is any fault in the manufacturing of the lens that would have brought rise to this cloudiness.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.Lenstec can also confirm that we have never had any confirmed lens-related cases of clouding, discolouration or opacification for our hema lenses.

• 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: 17195149
• MDR Text Key: 317812636
• Report Number: 9613160-2023-00007
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00844369027342
• UDI-Public: 00844369027342
• 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: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2020
• Device Model Number: SOFTECHD+21.25
• Device Catalogue Number: SOFTEC HD
• Device Lot Number: 145162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2015
• 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