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

Model Number	PCB00
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth, weight, ethnicity: unknown, information not provided.Date of event: unknown, not provided.If implanted, give date: unknown, information not provided.If explanted, give date: unknown, information not provided.Phone number: (b)(6).Fax number: (b)(6).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) was damaged.No further information was available.
Additional Manufacturer Narrative
Correction: per additional information received from the customer it was noted that the lens was broken during shipping.The outer shipping box was broken and the lens packaging was bent.When opened it was noted that the plunger was broken off from the injector.This occurred during shipping, and was not handed to the surgeon.Therefore, this event is no longer reportable as there is no indication of a malfunction or product quality deficiency.No further information received.Section h3-other (81): the intraocular lens (iol) was not returned for evaluation: the complaint is not reportable and cause is known therefore, there is no indication of a malfunction or product quality deficiency.No nonconformity report, escalation, documentation or labeling change is required.Amo puerto rico manufacturing / johnson and johnson surgical vision will continue to monitor this type of complaints.The following sections have been updated accordingly: section h6: medical device problem code: 2284 - device damaged prior to use.Section h6: type of investigation: 4114 - device not returned.Section h6: investigation findings: 3221 - no findings available.Section h6: investigation conclusions: 4308 - cause traced to transport/storage.All pertinent information available to johnson and 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
• MDR Report Key: 11441431
• Report Number: 2648035-2021-07336
• Device Sequence Number: 4048572
• Product Code: HQL
• UDI-Device Identifier: 05050474558212
• UDI-Public: (01)05050474558212(17)230619
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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: 06/19/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000175
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1