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

Model Number	SOFTECI+13.5
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lenstec is awaiting the arrival of the actual device to perform a comprehensive investigation.Once the investigation is complete a supplemental report will be submitted.
Event or Problem Description
Lenstec received an email stating " explanted due to significant capsular phimosis.The incision was enlarged with no patient injury.Another lens was implanted.".
Event or Problem Description
Lenstec received an email stating " explanted due to significant capsular phimosis.The incision was enlarged with no patient injury.Another lens was implanted.".
Additional Manufacturer Narrative
Based on the review of the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the device were conducted correctly.Additionally, we have not received any other complaints from this batch and the inspection revealed that the lens was intact; no damages or defects were noted.Capsular phimosis is a case of anterior capsular contraction syndrome (accs), usually related to the remnants of fibrous tissues that causes the anterior capsule to contract.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.

• Brand Name: SOFTEC I
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• Manufacturer (Section G): LENSTEC BARBADOS INC.; airport commercial centre; pilgrim road; christ church, ; BB
• Manufacturer Contact: jimmy chacko ; 1765 commerce ave. n.; st. petersburg, FL 33716 ; 7275712272
• MDR Report Key: 15642388
• Report Number: 9613160-2022-00018
• Device Sequence Number: 6444683
• Product Code: HQL
• UDI-Device Identifier: 00844369029230
• UDI-Public: 00844369029230
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 11/01/2022

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: 10/21/2025
• Device Model Number: SOFTECI+13.5
• Device Catalogue Number: SOFTEC I
• Device Lot Number: 203800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown