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

Model Number	SOFHDPLI+15.5D AND PLITIP1645 KIT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A full audit of all batch documentation relating to the production of the device was performed.The audit concluded that all procedures in manufacturing and packaging of the device had been conducted correctly.Batch reconciliation was 100.0%.Based on the assessment of our batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Lenstec believes that the lens, its design and the manufacturing process are not at fault due to extensive testing conducted on this model.
Event or Problem Description
Lenstec received an email stating "fibres have been noted either embedded into or adhered to the lens optic.These strands look similar to a crease in the lens optic yet do not dissipate".
Additional Manufacturer Narrative
A full audit of all batch documentation relating to the production of the device was performed.The audit concluded that all procedures in manufacturing and packaging of the device had been conducted correctly.Batch reconciliation was 100.0%.Based on the assessment of our batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Lenstec believes that the lens, its design and the manufacturing process are not at fault due to extensive testing conducted on this model.Pli lenses from the complaint batch were tested for injection integrity and no crease marks or particulate were found.
Event or Problem Description
Lenstec received an email stating "fibres have been noted either embedded into or adhered to the lens optic.These strands look similar to a crease in the lens optic yet do not dissipate".

• Brand Name: SOFTEC HD PLI
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• MDR Report Key: 11478425
• Report Number: 9613160-2021-00006
• Device Sequence Number: 4523616
• Product Code: HQL
• UDI-Device Identifier: 00844369002387
• UDI-Public: 00844369002387
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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: 10/18/2025
• Device Model Number: SOFHDPLI+15.5D AND PLITIP1645 KIT
• Device Catalogue Number: SOFTEC HD PLI
• Device Lot Number: S11987
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1