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

Model Number	SOFTECHDO+12.5
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has seemingly been explanted but not yet returned to lenstec for investigation.Furthermore, lenstec can also confirm that there have never been any confirmed lens-related cases of clouding, discoloration or opacification of our hema lenses.
Event or Problem Description
Lenstec received an email from sales personnel stating "dr.(b)(6) called to say he is removing a softec hd lens after a retina specialist did surgery and the lens calcified or covered with silicone oil".
Additional Manufacturer Narrative
Based on the assessment of the batch documentation, lenstec can confirm that all procedures in the manufacturing and packaging of the lens were conducted correctly.Additionally, there have not been any other complaints from this batch.Furthermore, lenstec can also confirm that there have never been any confirmed lens-related cases of clouding, discoloration, or opacification of our hema lenses.Microscopic examination of the lens revealed that the bubbles seen were superficial, as the stain for calcium did not extend through the lens matrix.According to neuhann et al, indicates the secondary calcification form refers to deposition of calcium onto the surface of the iol, most likely the result of environmental circumstances (e.G., changes in the aqueous milieu surrounding the implanted iol associated with preexisting or concurrent diseases or indeed any condition that has disrupted the blood aqueous barrier).By definition, it is not related to any problem with the iol itself.Lenstec's medical monitor reviewed the case and states the vitreoretinal surgery may also have pertained to calcification.
Event or Problem Description
Lenstec received an email from sales personnel stating " dr.(b)(6) called to say he is removing a softec hd lens after a retina specialist did surgery and the lens calcified or covered with silicone oil".

• Brand Name: SOFTEC HDO
• 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: 12967809
• Report Number: 9613160-2021-00023
• Device Sequence Number: 4534304
• Product Code: HQL
• UDI-Device Identifier: 00844369037105
• UDI-Public: 00844369037105
• 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: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2022

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: 05/25/2018
• Device Model Number: SOFTECHDO+12.5
• Device Catalogue Number: SOFTEC HDO
• Device Lot Number: 131540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2013
• 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