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

Model Number	SOFTECI+21.0
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2020
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.The visual examination carried out revealed that the lens was intact, and no defects were present.The cartridge was not returned but is compatible with the lens.Lenstec recommends the user follows the instructions for use for the correct procedure for implanting the lens.
Event or Problem Description
Lenstec received an email stating that 'surgical tech had problems getting lens to properly load.After several attempts was able to load.Md didn't feel comfortable on lens insertion and then removed.Removed lens, reinserted new lens without difficulty.Enlarged incision-no patient injury'.

• Brand Name: SOFTEC I
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 10303436
• Report Number: 9613160-2020-00058
• Device Sequence Number: 2865027
• Product Code: HQL
• UDI-Device Identifier: 00844369029483
• UDI-Public: 00844369029483
• 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
• Report Date (Section B): 07/21/2020

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: 03/02/2025
• Device Model Number: SOFTECI+21.0
• Device Catalogue Number: SOFTEC I
• Device Lot Number: 195061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1