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

Model Number	DCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.If implanted, give date: information unknown/not provided.If explanted, give date: information unknown/not provided.(b)(6).Device evaluation: the complaint product was received for evaluation.Device was not returned for evaluation and only the lens was received on a gauge and inside a plastic bag.There was no damage identified on lens.The miq (measuring iol quality) evaluation was performed to confirm the power and contrast of the lens.Miq measurement results revealed that the lens was correctly measured with satisfactory results (15.94 diopter and 0.132 contrast).Therefore, the reported issue was not verified.Based in the analysis no product deficiency was identified.Manufacturing record evaluation: the manufacturing record review (mrr) was conducted and no nonconformance reports/ discrepancies/ deviations for similar issues were found during manufacturing record review.The product was manufactured and released according to specifications.A search in complaint system revealed that no additional complaints was received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that postoperative examination (several days after surgery) revealed a refractive error (+4 ) diopter shift.The intraocular lens (iol) was removed without cut and another lens was inserted.No further information was provided.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12517005
• Report Number: 2020664-2021-07496
• Device Sequence Number: 4032124
• Product Code: HQL
• UDI-Device Identifier: 05050474636002
• UDI-Public: (01)05050474636002(17)230422
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2021

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: 04/22/2023
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention