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

Model Number	SOFTECHD+20.5
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	07/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Lenstec received an email stating, iol exchange due to haze/cloudiness.
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 haze/cloudiness seen were superficial, as it did not extend through the lens matrix.Lenstec's medical monitor is reviewing the case and a supplemental report will be provided once complete.
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 haze/cloudiness seen were superficial, as it did not extend through the lens matrix.Lenstec's medical monitor reviewed the case and states the patient's extensive comorbidities are likely the source of the haze/cloudiness seen.
Event or Problem Description
Lenstec received an email stating, iol exchange due to haze/cloudiness.

• Brand Name: SOFTEC HD
• 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: 15394116
• Report Number: 9613160-2022-00015
• Device Sequence Number: 6198159
• Product Code: HQL
• UDI-Device Identifier: 00844369027311
• UDI-Public: 00844369027311
• 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: 2015
• 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): 09/29/2022

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: 07/29/2019
• Device Model Number: SOFTECHD+20.5
• Device Catalogue Number: SOFTEC HD
• Device Lot Number: 142846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2014
• 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