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

Model Number	PCB00
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	Eye Injury (1845)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age or date of birth, weight, and ethnicity: unknown/ not provided.Date of event: exact date unknown, dates provided are (b)(6) 2021.However, it is unknown which date corresponds to the reported serial number.If implanted, give date: exact date unknown, dates provided are (b)(6) 2021.However, it is unknown which date corresponds to the reported serial number.If explanted, give date: not applicable, there is no indication iol was explanted.Reporter telephone number: (b)(6).Device evaluated by mfr: the intraocular lens (iol) was not returned for evaluation; as iol remains implanted.Therefore, a failure analysis of the complaint device cannot be completed.As the serial number of the device is unknown no further investigation can be performed.If there is any relevant information received, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
It was reported that after implantation of a pcb00 intraocular lens (iol), one of the handles (haptic) stayed folded in the wrong position and came out in the z position.Patient was permanently impaired.There was no further information provided.This report is 1 of 7.

• 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
• MDR Report Key: 12222349
• Report Number: 2648035-2021-08198
• Device Sequence Number: 4062561
• Product Code: HQL
• UDI-Device Identifier: 05050474558342
• UDI-Public: (01)05050474558342(17)231204
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2021

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: 12/04/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/23/2021
• 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: Other