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

Lot Number	SB07291
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2019
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.Approximately one-half of the lens was returned, thus limiting the inspection.However, no other defects or foreign particles were noted on the lens.The jagged edge appeared to be from the cut to facilitate removal of the lens from the eye.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 "lens was torn as it was being put into the eye.".

• 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: 9419131
• Report Number: 9613160-2019-00033
• Device Sequence Number: 19438991
• Product Code: HQL
• UDI-Device Identifier: 00844369029360
• UDI-Public: 00844369029360
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/05/2019

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: 07/28/2024
• Device Lot Number: SB07291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1