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

Model Number	SOFTECI+21.5
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/11/2020
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.Based on the investigation, lenstec concludes that the lens was handled incorrectly.
Event or Problem Description
Lenstec received an email stating " lens implanted (b)(6) 2020; explant date (b)(6) 2020.Lenstec received a form indicating 'broken haptic'.A back up lens was implanted and there was no patient injury or surgical intervention noted.

• 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: 11645265
• Report Number: 9613160-2021-00012
• Device Sequence Number: 3159914
• Product Code: HQL
• UDI-Device Identifier: 00844369029506
• UDI-Public: 00844369029506
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2021

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: 03/28/2024
• Device Model Number: SOFTECI+21.5
• Device Catalogue Number: SOFTEC I
• Device Lot Number: SB06216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1