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

Model Number	AAB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or date of birth, weight and ethnicity: unknown/ not provided.Explant date: not applicable, as lens was not explanted.(b)(6).Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing record evaluation: based on the manufacturing records review, and historical complaint review, there is no indication of a product malfunction or product quality deficiency.No nonconformity report, documentation or labeling changes, and escalations are required 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 during a routine phacoemulsification, at the irrigation/aspiration segment after intraocular lens (iol) implantation, the doctor noticed a shard of the optic part of the iol had broken off.However, the shard was not found in the eye later on.The lens remains implanted.The doctor planned to observe and no surgical intervention was performed.No other information was provided.

• Brand Name: SENSAR 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: 11807824
• Report Number: 2648035-2021-07788
• Device Sequence Number: 11622101
• Product Code: HQL
• UDI-Device Identifier: 05050474548664
• UDI-Public: (01)05050474548664(17)241005
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/11/2021

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: 10/05/2024
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000200
• 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: 04/12/2021
• Initial Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1