MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ethnicity: unknown, information was asked but not provided.Device evaluation: the product testing could not be performed as the device has not been returned for evaluation.The complaint issue reported could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed and no non-conformance report (nc) was found as part of this manufacturing records review.The product was manufactured and released according to specification.The search in complaint system revealed that no other complaints for this production order number have been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.Attempts were made to obtain the missing information; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
Health care provider reported that their patient is experiencing blurry vision in their right eye.The symptoms were reported one day post-op and are not debilitating.There were no complications or surgical interventions such as a capsule tear, unplanned vitrectomy or sutures.The iol was subsequently explanted.The replacement information was not provided.No further information was provided.
Additional Manufacturer Narrative
Corrected data: this is to correct the initial submission section e1 state, province, or territory: it is blank but should have stated california.Field below is updated: section e1 state, province, or territory: california.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Additional Manufacturer Narrative
Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jul 22, 2022.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint lens was received coated in viscoelastic residue and stuck the handpiece tray.The lens was cleaned and, no issues that could contribute to blurry vision could be identified.A product quality deficiency could not be determined.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15071639
• Report Number: 3012236936-2022-01840
• Device Sequence Number: 17518139
• Product Code: HQL
• UDI-Device Identifier: 05050474750753
• UDI-Public: (01)05050474750753(17)240925
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2022

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: 09/25/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 07/24/2022; 09/29/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 07/25/2022; 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Race: Asian