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

Model Number	SOFTECI+20.0
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2019
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.The lens was returned in two pieces and dehydrated.However, after hydration, the lens was viewed under a 10x magnification.A scratch was seen on the surface of the lens and the cross section of the optic was jagged which suggests the lens was caught and pulled during the attempted implantation, however, as the amo cartridge platinum cartridge was used, lenstec is unable to comment on its compatibility with the lens.Furthermore, lenstec confirms that the lens, its design and the manufacturing process are not at fault due to the extensive testing that we have performed on this model and lenstec advises the user to follow the correct method for implantation to prevent damage to the lens.
Event or Problem Description
Lenstec received an email stating that "cracked and torn lens.The incision was enlarged with no patient injury and another lens was used.The amo platinum cartridge was used.".

• 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: 9662024
• Report Number: 9613160-2020-00004
• Device Sequence Number: 16743155
• Product Code: HQL
• UDI-Device Identifier: 00844369029445
• UDI-Public: 00844369029445
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 02/03/2020

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: 03/21/2024
• Device Model Number: SOFTECI+20.0
• Device Catalogue Number: SOFTEC I
• Device Lot Number: SB06131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1