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

Model Number	SOFTECHD+20.0
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	03/09/2020
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 "haptic became stuck in the cartridge during insertion.Enlarged incision-no patient injury'.
Additional Manufacturer Narrative
Based on the batch documentation, lenstec can confirm that all procedures m the manufacturing and packaging of the device was conducted correctly.The results of the investigation indicated that the lens haptic appeared to have been caught and pulled which resulted in the damage seen.However, lenstec cannot comment on whether this damage was as a result of the cart45s cartridge as it was not returned for inspection.However, this cartridge and the lens are compatible and as such, lenstec advises the user to consult the instructions for use for the correct method for loading and ejecting the lens to ensure successful implantation.The missing optic area appeared to have been cut from the lens and the scratches seen were likely due to handling.
Event or Problem Description
Lenstec received an email stating that "haptic became stuck in the cartridge during insertion.Enlarged incision-no patient injury'.

• 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: 9963346
• Report Number: 9613160-2020-00011
• Device Sequence Number: 14138295
• Product Code: HQL
• UDI-Device Identifier: 00844369027298
• UDI-Public: 00844369027298
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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: 07/18/2024
• Device Model Number: SOFTECHD+20.0
• Device Catalogue Number: SOFTEC HD
• Device Lot Number: 192351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 07/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1