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

Model Number	SOFTECHD+21.25
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Lenstec received an email stating " lens is calcified-explanted.There was no patient injury and another lens was implanted.".
Event or Problem Description
Lenstec received an email stating " lens is calcified-explanted.There was no patient injury and another lens was implanted.".
Additional 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
• Common Device Name: 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
• Report Number: 9613160-2023-00007
• Device Sequence Number: 20244549
• Product Code: HQL
• UDI-Device Identifier: 00844369027342
• UDI-Public: 00844369027342
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2023

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown