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

Model Number	ZCB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact dates not provided, article acceptance date is december 29, 2020.Implant date: unknown, information not provided.Explant date: not applicable, as lens remains implanted.Device evaluation: product testing could not be performed since the device was not returned for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed one additional complaint folder was received for this po.No escalation required.Conclusion: a product deficiency has not been identified; therefore, no additional corrective actions have been initiated.
Event or Problem Description
The following article was received based on a literature review: article: a rare intraocular lens surface foreign body during phacoemulsification surgery: a case report a case report was done to present a rare case of an intraocular lens (iol) surface foreign body being tightly attached to the iol posterior surface during surgery, which seriously influenced the patient¿s postoperative visual acuity.A 76-year-old female with cataracts underwent phacoemulsification surgery on her right eye and implantation of the iol tecnis (zcb00; johnson & johnson vision).During surgery, once the optic region was implanted in the eye, the authors were surprised to observe a triangular transparent seemingly foreign body on the posterior surface of the iol.The patient underwent a second operation to remove the foreign body and improve the patient¿s visual acuity.The foreign body was evaluated by a fourier-transform infrared spectroscopy (ftir) and the results of this evaluation showed it was a polyethylene material.A copy of the article is provided with this report.Citation: li c, lu p.A rare intraocular lens surface foreign body during phacoemulsification surgery: a case report.Medicine 2021;100:3(e24391).

• 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: 16433554
• Report Number: 3012236936-2023-00473
• Device Sequence Number: 7459028
• Product Code: HQL
• UDI-Device Identifier: 05050474531611
• UDI-Public: (01)05050474531611(17)231024
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2023
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000150
• Was Device Available for Evaluation?: No
• 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: 01/27/2023
• Initial Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2019
• 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 Age: 76 YR
• Patient Sex: Female