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

Model Number	SOFTECHDM+20.5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Zonular Dehiscence (2698)
Date of Event	10/23/2019
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 and therefore, lenstec is unable to determine why the lens was decentered.Additional information has been requested from the facility and a supplemental report will be issued once received.
Event or Problem Description
Lenstec received an email stating that "intraocular lens exchanged due to lens decentered.".
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 and therefore, lenstec is unable to determine why the lens was decentered.This supplemental report reflects additional information and the complaint remains closed.
Event or Problem Description
Lenstec received an email stating that "intraocular lens exchanged due to lens decentered".

• Brand Name: SOFTEC HDM
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 9362561
• Report Number: 9613160-2019-00031
• Device Sequence Number: 16672818
• Product Code: HQL
• UDI-Device Identifier: 00844369039321
• UDI-Public: 00844369039321
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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: 08/24/2021
• Device Model Number: SOFTECHDM+20.5
• Device Catalogue Number: SOFTEC HDM
• Device Lot Number: 162439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1