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

Model Number	SOFTECHD+19.5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	06/02/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Furthermore, the actual device inspection yielded correct lens dimensions, was intact and undamaged.
Event or Problem Description
Lenstec received an email stating that "lens inserted, then removed due to posterior chamber rupture.".
Additional Manufacturer Narrative
Lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Furthermore, the actual device inspection yielded correct lens dimensions, was intact and undamaged.-.
Event or Problem Description
Lenstec received an email stating that "lens inserted, then removed due to posterior chamber rupture".
Additional Manufacturer Narrative
Lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Furthermore, the actual device inspection yielded correct lens dimensions, was intact and undamaged.-.
Event or Problem Description
Lenstec received an email stating that "lens inserted, then removed due to posterior chamber rupture".

• Brand Name: SOFTEC HD
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 10063109
• Report Number: 9613160-2020-00043
• Device Sequence Number: 16807495
• Product Code: HQL
• UDI-Device Identifier: 00844369027274
• UDI-Public: 00844369027274
• Combination Product (Y/N): N
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/30/2019
• Device Model Number: SOFTECHD+19.5
• Device Catalogue Number: SOFTEC HD
• Device Lot Number: F3490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Initial Date Received by Manufacturer: 06/15/2015
• Supplement Date Received by Manufacturer: 06/15/2015; 06/15/2015
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 05/19/2020; 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1