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

Model Number	SOFTECHD+19.5
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Lenstec received an email stating " the posterior loop of the lens was found broken when doing the surgery.The broken lens was explanted after enlarged the incision, and another softec hd was implanted.".
Additional 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%.The visual inspection performed on the device determined that the damage to the lens is consistent with the lens being caught and pulled in the injector.The injector used was not part of lenstec's validated device delivery systems for use listed in the ifu.Lenstec cannot comment of the compatability of the injector that was used with the this lens.

• 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: 13343773
• Report Number: 9613160-2022-00005
• Device Sequence Number: 4127636
• Product Code: HQL
• UDI-Device Identifier: 00844369027274
• UDI-Public: 00844369027274
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/24/2022

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: 06/25/2026
• Device Model Number: SOFTECHD+19.5
• Device Catalogue Number: SOFTEC HD
• Device Lot Number: 212206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2021
• 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