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

Model Number	SOFTECHDM+18.25
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lenstec can confirm that all procedures in the manufacturing and packaging of the lens was conducted correctly.When the device can be fully investigated a supplemental report will be submitted.
Event or Problem Description
Lenstec received an email stating that 'lens was seen scratched after implantation.Enlarged incision-no patient injury'.
Event or Problem Description
Lenstec received an email stating that 'lens was seen scratched after implantation.Enlarged incision-no patient injury'.
Additional Manufacturer Narrative
This is the supplemental report based on the remainder of the investigation since the lens was returned.Lenstec can confirm that all procedures in the manufacturing and packaging of the lens was conducted correctly.No instruments were mentioned as being used and lenstec recommends that the surgeon follow the ifu for the correct procedure and instruments used for implanting purposes to avoid an optic scratch.

• 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: 9963349
• Report Number: 9613160-2020-00012
• Device Sequence Number: 2740626
• Product Code: HQL
• UDI-Device Identifier: 00844369039239
• UDI-Public: 00844369039239
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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: 08/25/2021
• Device Model Number: SOFTECHDM+18.25
• Device Catalogue Number: SOFTEC HDM
• Device Lot Number: 162723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1