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

Lot Number	SB03275
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Deposits (1809)
Date of Event	05/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the review conducted on this case, lenstec was unable to perform a more thorough investigation of the complaint as the lens remains implanted.Therefore, we are unable to comment on the nature of the reported incident described and cannot corroborate the claim of actual opacification or make any definitive statement as to its cause.However, we can confirm that a lens of this nature would not have been shipped.Additionally, lenstec can confirm that all procedures in the manufacturing and packaging of the device were conducted correctly.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.Based on the medical' s monitor assessment, the complaint does not seem to be inflammatory in nature.The pupil appears to be irregular, suggesting some perioperative abnormality.Lenstec can also confirm that there have never been any confirmed lens-related cases of clouding, discoloration or opacification for our hema lenses.(b)(4).
Event or Problem Description
Lenstec received an email stating that "a patient was implanted with softec hd pli on may 14th.The doctor found that the edge of the optical zone of the iol was blurred and there were small white spots on the edge of the iol that could be scrapped off during the surgery.It was found that the central lens was transparent without mydriasis and the visual acuity was normal on one week review." the lens remains implanted , there was no patient injury or surgical intervention.
Event or Problem Description
Lenstec received an email stating that "a paiteint was implanted with softec hd pli on may 14th.The doctor found that the edge of the optical zone of the iol was blurred and there were small white spots on the edge of the iol that could be scrapped off during the surgery.It was found that the central lens was transparent without mydriasis and the visual acuity was normal on one week review." the lens remains implanted , there was no patient injury or surgical intervention.
Additional Manufacturer Narrative
Based on the review conducted on this case, lenstec was unable to perform a more thorough investigation of the complaint as the lens remains implanted.Therefore, we are unable to comment on the nature of the reported incident described and cannot corroborate the claim of actual opacification or make any definitive statement as to its cause.However, we can confirm that a lens of this nature would not have been shipped.Additionally, lenstec can confirm that all procedures in the manufacturing and packaging of the device were conducted correctly.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.Based on the medical' s monitor assessment, the complaint does not seem to be inflammatory in nature.The pupil appears to be irregular, suggesting some perioperative abnormality.Lenstec can also confirm that there have never been any confirmed lens-related cases of clouding, discoloration or opacification for our hema lenses.(b)(4).
Event or Problem Description
Lenstec received an email stating that "a patient was implanted with softec hd pli on may 14th.The doctor found that the edge of the optical zone of the iol was blurred and there were small white spots on the edge of the iol that could be scrapped off during the surgery.It was found that the central lens was transparent without mydriasis and the visual acuity was normal on one week review." the lens remains implanted , there was no patient injury or surgical intervention.
Additional Manufacturer Narrative
Based on the review conducted on this case, lenstec was unable to perform a more thorough investigation of the complaint as the lens remains implanted.Therefore, we are unable to comment on the nature of the reported incident described and cannot corroborate the claim of actual opacification or make any definitive statement as to its cause.However, we can confirm that a lens of this nature would not have been shipped.Additionally, lenstec can confirm that all procedures in the manufacturing and packaging of the device were conducted correctly.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.Based on the medical' s monitor assessment, the complaint does not seem to be inflammatory in nature.The pupil appears to be irregular, suggesting some perioperative abnormality.Lenstec can also confirm that there have never been any confirmed lens-related cases of clouding, discoloration or opacification for our hema lenses.

• 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: 8719714
• Report Number: 9613160-2019-00020
• Device Sequence Number: 16660384
• Product Code: HQL
• UDI-Device Identifier: 00844369002813
• UDI-Public: 00844369002813
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P090022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2019

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: 05/04/2020
• Device Lot Number: SB03275
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 05/24/2019; 05/24/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 07/19/2019; 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1