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

Lot Number	161333
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2019
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.Due to the absence of the lens, lenstec was unable to perform a more thorough investigation of the complaint.We are therefore unable to determine a specific cause for the damage observed on the haptic.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.
Event or Problem Description
Lenstec received an email stating that "haptic bent and broke during insertion, lens had to be cut out and replaced".

• 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: 9012596
• Report Number: 9613160-2019-00025
• Device Sequence Number: 16606586
• Product Code: HQL
• UDI-Device Identifier: 00844369039529
• UDI-Public: 00844369039529
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 09/12/2019

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: 05/21/2021
• Device Lot Number: 161333
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1