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

Model Number	SOFTECHDM+19.0
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2019
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.One haptic was intact and the tip of the other was missing and no marks or defects were seen on the surface of the lens.The cross section of the haptic was jagged which suggests the haptic broke as a result of being caught and torn during the attempted implantation.No information was provided on the type of cartridge or injector used and therefore, lenstec cannot comment on the compatibility of the lens and injection system utilized.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 'loading issues and broken haptic.The incision was enlarged with no patient injury and another lens was used.".

• 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: 9662109
• Report Number: 9613160-2020-00006
• Device Sequence Number: 3392737
• Product Code: HQL
• UDI-Device Identifier: 00844369039260
• UDI-Public: 00844369039260
• 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: 10/14/2023
• Device Model Number: SOFTECHDM+19.0
• Device Catalogue Number: SOFTEC HDM
• Device Lot Number: SB04384
• 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