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

Model Number	ZA9003
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth, weight, ethnicity: unknown/not provided.If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Telephone number: (b)(6).The device is not returning for evaluation as mentioned by the account; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after implantation of the intraocular lens (iol), the surgeon noticed that the lens haptic was detached.He had to remove the lens and implant a new one.No patient injury was reported.The material is not available for investigation.

• 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: 12147590
• Report Number: 2648035-2021-08042
• Device Sequence Number: 4259360
• Product Code: HQL
• UDI-Device Identifier: 05050474528932
• UDI-Public: (01)05050474528932(17)250901
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P990080
• 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): 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2025
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030160
• 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: 06/10/2021
• Initial Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1