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

Model Number	SOFTECHD+22.0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has seemingly been explanted but was discarded by facility prior to returning.Furthermore, lenstec can also confirm that all production records met process controls and final inspection criteria.
Event or Problem Description
Lenstec received an email from stating " original lens hd +22.0 implanted and patient was experiencing anisometropia.Removed lens and implanted hd +19.0 without need for stitches to retian th elens and no adverse event for the patient.
Additional Manufacturer Narrative
The device has seemingly been explanted but was discarded by facility prior to returning.Furthermore, lenstec can also confirm that all production records met process controls and final inspection criteria.Based on the review of the batch documentation conducted, lenstec can confirm that all procedures in the manufacturing of the device were conducted correctly, and the quality of the lens is not at fault.The lens was within the tolerance range for +22.0d.
Event or Problem Description
Lenstec received an email notification stating 'original lens hd +22.0 implanted and patient was experiencing anisometropia.Removed lens and implanted hd +18.0 without need for stitches to retain the lens and no adverse event for the patient'.

• 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: 14365735
• Report Number: 9613160-2022-00007
• Device Sequence Number: 11252492
• Product Code: HQL
• UDI-Device Identifier: 00844369027373
• UDI-Public: 00844369027373
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2026
• Device Model Number: SOFTECHD+22.0
• Device Catalogue Number: SOFTEC HD
• Device Lot Number: SB11660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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